Progress in Quantitative Methods for Azelnidipine and Chlorthalidone:
An Analytical Basis for a Recently Approved FDC

Juhi      Raimalani; Rajendra      Kotadiya
doi:10.2174/1573412919666221025124218
Abstract

Background: Products with multiple active substances mixed in a single dosage form are fixed-dose combinations. These are justified for a variety of reasons. These include a) increasing therapeutic efficacy, b) lowering adverse drug effects, c) pharmacokinetic advantages, d) lowering pill load, e) lowering individual drug doses, and f) lowering drug resistance development.
Objective: A recently approved fixed dose combination of azelnidipine (8 mg) and chlorthalidone (6.25 or 12.5 mg) is indicated to treat hypertension. Individual quantification methods for azelnidipine and chlorthalidone are available, but no practical and acceptable analytical approach for their combination has been documented. As a result, the goal of this literature review was to gather information on numerous analytical instrumental approaches utilized to quantify azelnidipine and chlorthalidone in diverse matrices individually. The scientific community could use this information to design a new analytical method for analysing the recently approved combination.
Methods: Authors have explored various scientific databases to obtain information on analytical methods.
Results: The methods listed for azelnidipine and chlorthalidone are spectroscopy, highperformance liquid chromatography, hyphenated techniques, high-performance thin-layer chromatography, thin-layer chromatography, and a few other approaches. For azelnidipine and chlorthalidone, there were 26 and 46 research papers reported, respectively.
« Previous Next »
Graphical Abstract

[1]
Godman, B.; McCabe, H.; D., Leong T.; Mueller, D.; Martin, A.P.; Hoxha, I.; Mwita, J.C.; Rwegerera, G.M.; Massele, A.; Costa, J.O.; do Nascimento, R.C.R.M.; Lemos, L.L.P.; Tachkov, K.; Milushewa, P.; Patrick, O.; Niba, L.L.; Laius, O.; Sefah, I.; Abdulsalim, S.; Soleymani, F.; Guantai, A.N.; Achieng, L.; Oluka, M.; Jakupi, A.; Logviss, K.; Hassali, M.A.; Kibuule, D.; Kalemeera, F.; Mubita, M.; Fadare, J.; Ogunleye, O.O.; Saleem, Z.; Hussain, S.; Bochenek, T.; Mardare, I.; Alrasheedy, A.A.; Furst, J.; Tomek, D.; Markovic-Pekovic, V.; Rampamba, E.M.; Alfadl, A.; Amu, A.A.; Matsebula, Z.; Phuong, T.N.T.; Thanh, B.N.; Chichonyi Kalungia, A.; Zaranyika, T.; Masuka, N.; Olaru, I.D.; Wale, J.; Hill, R.; Kurdi, A.; Timoney, A.; Campbell, S.; Meyer, J.C. Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries. Expert Rev. Pharmacoecon. Outcomes Res.,  2020, 20(1), 1-26.
 [http://dx.doi.org/10.1080/14737167.2020.1734456] [PMID:  32237953]

[2]
Okamura, K.; Yano, Y.; Takamiya, Y.; Shirai, K.; Urata, H. Efficacy and safety of a combination antihypertensive drug (olmesartan plus azelnidipine): “Issues with hypertension studies in real-world practice. Clin. Exp. Hypertens.,  2020, 42(5), 438-448.
 [http://dx.doi.org/10.1080/10641963.2019.1693586] [PMID:  31756122]

[3]
Taddei, S. Fixed-dose combination therapy in hypertension. Pros. High Blood Press. Cardiovasc. Prev.,  2012, 19(2), 55-57.
 [http://dx.doi.org/10.1007/BF03262454] [PMID:  22867090]

[4]
Black, H.R. Triple fixed-dose combination therapy: Back to the past. Hypertension,  2009, 54(1), 19-22.
 [http://dx.doi.org/10.1161/HYPERTENSIONAHA.109.132688] [PMID:  19470871]

[5]
Kawalec, P.; Holko, P.; Gawin, M.; Pilc, A. Effectiveness of fixed-dose combination therapy in hypertension: Systematic review and meta-analysis. Arch. Med. Sci.,  2018, 14(5), 1125-1136.
 [http://dx.doi.org/10.5114/aoms.2018.77561] [PMID:  30154897]

[6]
Shah, J.; Kotadiya, R. A critical review on analytical methods for recently approved FDC drugs: Pregabalin and etoricoxib. Crit. Rev. Anal. Chem.,  2020, 2020, 1855411.
 [http://dx.doi.org/10.1080/10408347.2020.1855411] [PMID:  33307732]

[7]
Lederle, F.A.; Cushman, W.C.; Ferguson, R.E.; Brophy, M.T.; Fiore Md, L.D. Chlorthalidone versus hydrochlorothiazide: A new kind of veterans affairs cooperative study. Ann. Intern. Med.,  2016, 165(9), 663-664.
 [http://dx.doi.org/10.7326/M16-1208] [PMID:  27538129]

[8]
Yamagishi, T. Efficacy of azelnidipine on home blood pressure and pulse rate in patients with essential hypertension: Comparison with amlodipine. Hypertens. Res.,  2006, 29(10), 767-773.
 [http://dx.doi.org/10.1291/hypres.29.767] [PMID:  17283863]

[9]
Oparil, S.; Acelajado, M.C.; Bakris, G.L.; Berlowitz, D.R.; Cífková, R.; Dominiczak, A.F.; Grassi, G.; Jordan, J.; Poulter, N.R.; Rodgers, A.; Whelton, P.K. Hypertension. Nat. Rev. Dis. Primers,  2018, 4(1), 18014.
 [http://dx.doi.org/10.1038/nrdp.2018.14] [PMID:  29565029]

[10]
Hripcsak, G.; Suchard, M.A.; Shea, S.; Chen, R.; You, S.C.; Pratt, N.; Madigan, D.; Krumholz, H.M.; Ryan, P.B.; Schuemie, M.J. Comparison of cardiovascular and safety outcomes of chlorthalidone vs hydrochlorothiazide to treat hypertension. JAMA Intern. Med.,  2020, 180(4), 542-551.
 [http://dx.doi.org/10.1001/jamainternmed.2019.7454] [PMID:  32065600]

[11]
Chauhan, N.N. An analytical approach of azelnidipine A review. World J. Pharm. Pharm. Sci.,  2021, 10(3), 682-692.
 [http://dx.doi.org/10.20959/wjpps20213-18460]

[12]
Kannan, A.; Nagarajan, J.S.K. A review on bioanalytical method development and validation for the estimation of metformin in biological matrices. Int. J. Pharmaceut. Res.,  2021, 13(2), 272-278.
 [http://dx.doi.org/10.31838/ijpr/2021.13.02.220]

[13]
Patel, K.; Mahida, R. A review on analytical methods for estimation of azelnidipine and telmisartan in pharmaceutical dosage form. World J. Pharm. Res.,  2021, 10(4), 20093.
 [http://dx.doi.org/10.20959/wjpr20214-20093]

[14]
Uesawa, Y.; Takeuchi, T.; Mohri, K. Integrated analysis on the physicochemical properties of dihydropyridine calcium channel blockers in grapefruit juice interactions. Curr. Pharm. Biotechnol.,  2012, 13(9), 1705-1717.
 [http://dx.doi.org/10.2174/138920112800958878] [PMID:  22039822]

[15]
Wellington, K.; Scott, L.J. Azelnidipine. Adis Int. Limited, Auckland. New Zeal.,  2003, 63(23), 2613-2621.

[16]
Zou, J.J.; Ji, H.J.; Zhou, X.H.; Zhu, Y.B.; Fan, H.W.; Xiao, D.W.; Hu, Q. Determination of azelnidipine by LC-ESI-MS and its application to a pharmacokinetic study in healthy Chinese volunteers. Pharmazie,  2008, 63(8), 568-570.
 [http://dx.doi.org/10.1691/ph.2008.8062] [PMID:  18771003]

[17]
Kuramoto, K.; Ichikawa, S.; Hirai, A.; Kanada, S.; Nakachi, T.; Ogihara, T. Azelnidipine and amlodipine: A comparison of their pharmacokinetics and effects on ambulatory blood pressure. Hypertens. Res.,  2003, 26(3), 201-208.
 [http://dx.doi.org/10.1291/hypres.26.201] [PMID:  12675275]

[18]
Tanigawara, Y.; Yoshihara, K.; Kuramoto, K.; Arakawa, K. Comparative pharmacodynamics of olmesartan and azelnidipine in patients with hypertension: A population pharmacokinetic/pharmacodynamic analysis. Drug Metab. Pharmacokinet.,  2009, 24(4), 376-388.
 [http://dx.doi.org/10.2133/dmpk.24.376] [PMID:  19745564]

[19]
Chen, B.L.; Zhang, Y.Z.; Luo, J.Q.; Zhang, W. Clinical use of azelnidipine in the treatment of hypertension in Chinese patients. Ther. Clin. Risk Manag.,  2015, 11, 309-318.
 [PMID:  25750535]

[20]
Bonfilio, R.; Leal, J.S.; Santos, O.M.M.; Pereira, G.R.; Doriguetto, A.C.; de Araújo, M.B. Analysis of chlorthalidone polymorphs in raw materials and tablets and the effect of forms I and II on the dissolution properties of drug products. J. Pharm. Biomed. Anal.,  2014, 88, 562-570.
 [http://dx.doi.org/10.1016/j.jpba.2013.10.020] [PMID:  24216278]

[21]
Degen, P.H.; Schweizer, A. Quantitative determination of drugs in biological materials by means of extractive alkylation and gas-liquid chromatography. J. Chromatogr. A,  1977, 142, 549-557.
 [http://dx.doi.org/10.1016/S0021-9673(01)92067-9] [PMID:  914935]

[22]
Seong, S.J.; Lim, M.; Lee, J.; Ohk, B.; Gwon, M.R.; Kim, B.K.; Kim, H.J.; Yang, D.H.; Lee, H.W.; Kang, W.Y.; Yoon, Y.R. Evaluation of a pharmacokinetic interaction between telmisartan and chlorthalidone in healthy male adult subjects. Clin. Drug Investig.,  2016, 36(8), 613-623.
 [http://dx.doi.org/10.1007/s40261-016-0406-y] [PMID:  27206575]

[23]
Madagul, J.K.; Parakh, D.R.; Kumar, R.S. Formulation and evaluation of solid self micro- emulsifying drug delivery system (S-SMEDDS) of chlorthalidone by spray drying technology.  Dry. Technol. An Int. J.,  2016, 3937, 1201833.
 [http://dx.doi.org/10.1080/07373937.2016.1201833]

[24]
Singer, J.M.; Hare, M.J.O.; Rehrn, C.R.; Zarembo, J.E.  Chlorthalidone. In: Revlon Heulth Care Gr. Tuckuhoe, New York;  , 1985.  14

[25]
Beermann, B.; Groschinsky-Grind, M. Clinical pharmacokinetics of diuretics. Clin. Pharmacokinet.,  1980, 5(3), 221-245.
 [http://dx.doi.org/10.2165/00003088-198005030-00003] [PMID:  6993083]

[26]
Carter, B.L.; Ernst, M.E.; Cohen, J.D. Hydrochlorothiazide versus chlorthalidone: Evidence supporting their interchangeability. Hypertension,  2004, 43(1), 4-9.
 [http://dx.doi.org/10.1161/01.HYP.0000103632.19915.0E] [PMID:  14638621]

[27]
Fleuren, H.L.J.; van Rossum, J.M. Nonlinear relationship between plasma and red blood cell pharmacokinetics of chlorthalidone in man. J. Pharmacokinet. Biopharm.,  1977, 5(4), 359-375.
 [http://dx.doi.org/10.1007/BF01061696] [PMID:  894487]

[28]
Fleuren, H.L.J.; Wissen, C.V.; van Rossum, J.M. Dose-dependent urinary excretion of chlorthalidone. Clin. Pharmacol. Ther.,  1979, 25(6), 806-812.
 [http://dx.doi.org/10.1002/cpt1979256806] [PMID:  445947]

[29]
Mulley, B.A.; Parr, G.D.; Rye, R.M. Pharmacokinetics of chlorthalidone. Eur. J. Clin. Pharmacol.,  1980, 17(3), 203-207.
 [http://dx.doi.org/10.1007/BF00561901] [PMID:  6767611]

[30]
Riess, W.; Dubach, U.C.; Burckhardt, D.; Theobald, W.; Vuillard, P.; Zimmerli, M. Pharmacokinetic studies with chlorthalidone (hygroton) in man. Eur. J. Clin. Pharmacol.,  1977, 12(5), 375-382.
 [http://dx.doi.org/10.1007/BF00562454] [PMID:  598410]

[31]
Pallavi, M.; Patil, N. Hplc method development - a review. J. Pharm. Res. Educ.,  2017, 1(2), 243-260.

[32]
Kawai, Y.; Fujii, Y.; Tabata, F.; Ito, J.; Metsugi, Y.; Kameda, A.; Akimoto, K.; Takahashi, M. Profiling and trend analysis of food effects on oral drug absorption considering micelle interaction and solubilization by bile micelles. Drug Metab. Pharmacokinet.,  2011, 26(2), 180-191.
 [http://dx.doi.org/10.2133/dmpk.DMPK-10-RG-098] [PMID:  21206132]

[33]
Rashad, A.A.; El-helaly, S.N.; Abd, R.T.; Rehim, E.; El-gazayerly, O.N. Chronological delivery of antihypertensive drugs in bilayered core-in-cup buccoadhesive tablets: In vitro and in vivo evaluation. vAAPS PharmSciTech, 2019, 21(1), 21.
 [http://dx.doi.org/10.1208/s12249-019-1575-9]

[34]
Rashad, A.A.; El-Helaly, S.N.; Abd El Rehim, R.T.; El-Gazayerly, O.N. Core-in-cup/liquisol dual tackling effect on azelnidipine buccoadhesive tablet micromeritics, in vitro release, and mucoadhesive strength. Acta Pharm.,  2019, 69(3), 381-398.
 [http://dx.doi.org/10.2478/acph-2019-0022] [PMID:  31259736]

[35]
Chen, M.L.; Sadrieh, N.; Yu, L. Impact of osmotically active excipients on bioavailability and bioequivalence of BCS class III drugs. AAPS J.,  2013, 15(4), 1043-1050.
 [http://dx.doi.org/10.1208/s12248-013-9509-z] [PMID:  23868749]

[36]
Dangre, P.V.; Gilhotra, R.M.; Dhole, S.N. Formulation and development of solid self micro-emulsifying drug delivery system (S-SMEDDS) containing chlorthalidone for improvement of dissolution. J. Pharm. Investig.,  2016, 46(7), 633-644.
 [http://dx.doi.org/10.1007/s40005-016-0243-2]

[37]
Dash, R.P.; Srinivas, N.R.; Babu, R.J. Use of sorbitol as pharmaceutical excipient in the present day formulations – issues and challenges for drug absorption and bioavailability. Drug Dev. Ind. Pharm.,  2019, 45(9), 1421-1429.
 [http://dx.doi.org/10.1080/03639045.2019.1640722] [PMID:  31271324]

[38]
Pan, Y.; Pang, W.; Lv, J.; Wang, J.; Yang, C.; Guo, W. Solid state characterization of azelnidipine–oxalic acid co-crystal and co-amorphous complexes: The effect of different azelnidipine polymorphs. J. Pharm. Biomed. Anal.,  2017, 138, 302-315.
 [http://dx.doi.org/10.1016/j.jpba.2017.02.005] [PMID:  28237872]

[39]
Du, S.; Li, W.S.; Wu, Y.R.; Fu, Y.; Yang, C.; Wang, J. Comparison of the physical and thermodynamic stability of amorphous azelnidipine and its coamorphous phase with piperazine. RSC Advances,  2018, 8(57), 32756-32764.
 [http://dx.doi.org/10.1039/C8RA05535A] [PMID:  35547669]

[40]
Gaikwad, S.S.; Avari, J.G. Improved bioavailability of Azelnidipine gastro retentive tablets-optimization and in-vivo assessment. Mater. Sci. Eng. C,  2019, 103, 109800.
 [http://dx.doi.org/10.1016/j.msec.2019.109800] [PMID:  31349458]

[41]
Lian, W.; Lin, Y.; Wang, M.; Yang, C.; Wang, J. Crystal engineering approach to produce complex of azelnidipine with maleic acid. CrystEngComm,  2013, 15(19), 3885-3891.
 [http://dx.doi.org/10.1039/c3ce26967a]

[42]
França, M.T.; Nicolay Pereira, R.; Klüppel Riekes, M.; Munari Oliveira Pinto, J.; Stulzer, H.K. Investigation of novel supersaturating drug delivery systems of chlorthalidone: The use of polymer-surfactant complex as an effective carrier in solid dispersions. Eur. J. Pharm. Sci.,  2018, 111, 142-152.
 [http://dx.doi.org/10.1016/j.ejps.2017.09.043] [PMID:  28964949]

[43]
Mironneau, J.; Savineau, J.P.; Mironneau, C. Compared effects of indapamide, hydrochlorothiazide and chlorthalidone on electrical and mechanical activities in vascular smooth muscle. Eur. J. Pharmacol.,  1981, 75(2-3), 109-113.
 [http://dx.doi.org/10.1016/0014-2999(81)90068-6] [PMID:  7318900]

[44]
Lötter, J.; Krieg, H.M.; Keizer, K.; Breytenbach, J.C. The influence of β-cyclodextrin on the solubility of chlorthalidone and its enantiomers. Drug Dev. Ind. Pharm.,  1999, 25(8), 879-884.
 [http://dx.doi.org/10.1081/DDC-100102248] [PMID:  10434131]

[45]
Zhu, H-L.; Tomoda, T.; Aishima, M.; Ito, Y.; Teramoto, N. The actions of azelnidipine, a dihydropyridine-derivative Ca antagonist, on voltage-dependent Ba2+ currents in guinea-pig vascular smooth muscle. Br. J. Pharmacol.,  2006, 149(6), 786-796.
 [http://dx.doi.org/10.1038/sj.bjp.0706919] [PMID:  17016499]

[46]
Iwai, M.; Li, H.S.; Chen, R.; Shiuchi, T.; Wu, L.; Min, L.J.; Li, J.M.; Tsuda, M.; Suzuki, J.; Tomono, Y.; Tomochika, H.; Mogi, M.; Horiuchi, M. Calcium channel blocker azelnidipine reduces glucose intolerance in diabetic mice via different mechanism than angiotensin receptor blocker olmesartan. J. Pharmacol. Exp. Ther.,  2006, 319(3), 1081-1087.
 [http://dx.doi.org/10.1124/jpet.106.108894] [PMID:  16990512]

[47]
Sica, D.A. Chlorthalidone. Hypertension,  2006, 47(3), 321-322.
 [http://dx.doi.org/10.1161/01.HYP.0000203147.75714.ba] [PMID:  16446394]

[48]
Vaughan, E.D., Jr; Laragh, J.H.; Gavras, I.; Bühler, F.R.; Gavras, H.; Brunner, H.R.; Baer, L. Volume factor in low and normal renin essential hypertension. Am. J. Cardiol.,  1973, 32(4), 523-532.
 [http://dx.doi.org/10.1016/S0002-9149(73)80044-X] [PMID:  4729722]

[49]
Roush, G.C.; Buddharaju, V.; Ernst, M.E.; Holford, T.R. Chlorthalidone: Mechanisms of action and effect on cardiovascular events. Curr. Hypertens. Rep.,  2013, 15(5), 514-521.
 [http://dx.doi.org/10.1007/s11906-013-0372-1] [PMID:  23839110]

[50]
Konari, S.N.; Prakash, V. Spectrophotometric method development and validation for estimation of aceclofenac in pharmaceutical dosage form. Int. J. Pharm. Res.,  2012, 4(4), 92-94.

[51]
Mukeri, I.H.; Kushwaha, A.K.; Neupane, N.P.; Kumar, A. Analytical method development and validation of azelnidipine. World J. Pharm. Res.,  2021, 10, 858-872.
 [http://dx.doi.org/10.20959/wjpr202110-21174]

[52]
Patel, N.; Patel, J.K. Simultaneous determination of azelnidipine and olmesartan medoxomil by first derivative spectrophotometric method. Pharm. Lett.,  2012, 4(4), 1080-1084.

[53]
Rele Rajan, V. Spectrophotometric estimation of azelnidipine in bulk and pharmaceutical dosage form by second order derivative methods. J. Chem. Pharm. Res.,  2014, 6(8), 198-202.

[54]
Attimarad, M.; Chohan, M.S.; Katharigatta Narayanaswamy, V.; Nair, A.B.; Sreeharsha, N.; Shafi, S.; David, M.; Balgoname, A.A.; Altaysan, A.I.; Molina, E.I.I.P.; Deb, P.K. Mathematically processed UV spectroscopic method for quantification of chlorthalidone and azelnidipine in bulk and formulation: Evaluation of greenness and whiteness. J. Spectrosc.,  2022, 2022, 4965138.
 [http://dx.doi.org/10.1155/2022/4965138]

[55]
More, S.; Tamboli, A.; Patil, S.; Vhanmane, A.; Parmar, H.; Dey, S.; Upadhyay, U.; Simultaneous, U.V. Simultaneous UV spectrophotometric estimation of amlodipine and chlorthalidone in bulk and combined tablet dosage form. Int. J. Sci. Res. Sci. Technol.,  2019, 2019, 468-472.
 [http://dx.doi.org/10.32628/IJSRST196168]

[56]
Abdullah, N.S.; Hassan, M.A.; Hassan, R.O. Spectrophotometric determination of chlorthalidone in pharmaceutical formulations using different order derivative methods. Arab. J. Chem.,  2017, 10, S3426-S3433.
 [http://dx.doi.org/10.1016/j.arabjc.2014.02.002]

[57]
Ingle, S.; Patil, P.; Kulkarni, V.; Patil, S.; Salunke, P. Development and Validation of Uv spectrophotometric method for chlorthalidone in bulk and pharmaceutical dosage forms. Health Qual. Life Outcomes,  2007, 5(1), 63.

[58]
Bamgonde, S.; Dulange, K.; Kalshetti, M.; Gaibu, Z. UV- spectrophotometric method development and validation for determination of chlorthalidone in bulk and pharmaceutical dosage form. Asian J. Pharm. Anal. Med. Chem.,  2019, 5(1), 49-59.

[59]
Martins, Y.A.; De Oliveira, C.L.C.G. Development and validation of an UV spectrophotometric method for determination of thiamphenicol in dosage form. J. Appl. Spectrosc.,  2019, 86(4), 629-635.
 [http://dx.doi.org/10.1007/s10812-019-00870-w]

[60]
Patel, S.; Hinge, M.; Bhanushali, V. Development and validation of an UV spectrophotometric method for simultaneous determination of cilnidipine and chlorthalidone. J. Pharm. Res.,  2015, 9(1), 41-45.

[61]
Sawale, V.; Dhabarde, D.; Kar Mahapatra, D. Development and validation of UV spectrophotometric method for simultaneous estimation of olmesartan medoxomil and chlorthalidone in bulk and tablet. Eurasian J. Anal. Chem.,  2016, 12(1), 55-66.
 [http://dx.doi.org/10.12973/ejac.2017.00144a]

[62]
Ebeid, W.M.; Elkady, E.; El-Zaher, A. EL-Bagary, R.; Patonay, G. Spectrophotometric and spectrofluorimetric studies on azilsartan medoxomil and chlorthalidone to be utilized in their determination in pharmaceuticals. Anal. Chem. Insights,  2014, 9, 33-40.
 [http://dx.doi.org/10.4137/ACI.S13768] [PMID:  24855334]

[63]
Charde, M. Inclusion of Hydrophilic-Lipophilic Balance (HLB) in the Treatment of Psoriasis-A New Approach QR Code. Int. J. Adv. Pharmaceut.,  2014, 3(1), e5150.
 [http://dx.doi.org/10.7439/ijap]

[64]
Sancho, M.I.; Almandoz, M.C.; Blanco, S.E.; Castro, E.A. Spectroscopic study of solvent effects on the electronic absorption spectra of flavone and 7-hydroxyflavone in neat and binary solvent mixtures. Int. J. Mol. Sci.,  2011, 12(12), 8895-8912.
 [http://dx.doi.org/10.3390/ijms12128895] [PMID:  22272110]

[65]
Rane, A.S.; Mahajan, S.K. Validation and forced stability-indicating Hptlc method for determination of azelnidipine. World J. Pharm. Res.,  2016, 5(9), 1053-1062.
 [http://dx.doi.org/10.20959/wjpr20169-6930]

[66]
Youssef, R.M.; Maher, H.M.; El-Kimary, E.I.; Hassan, E.M.; Barary, M.H. Validated stability-indicating methods for the simultaneous determination of amiloride hydrochloride, atenolol, and chlorthalidone using HPTLC and HPLC with photodiode array detector. J. AOAC Int.,  2013, 96(2), 313-323.
 [http://dx.doi.org/10.5740/jaoacint.11-347] [PMID:  23767356]

[67]
Rathod, R.H.; Patil, A.S.; Shirkhedkar, A.A. Novel NP and RP-HPTLC in praxis for simultaneous estimation of chlorthalidone and cilnidipine in bulk and pharmaceutical formulation. Anal. Chem. Lett.,  2018, 8(6), 862-871.
 [http://dx.doi.org/10.1080/22297928.2018.1527252]

[68]
Vyas, A.J.; Gol, D.A.; Usdad, R.G.; Patel, A.I.; Patel, A.B.; Patel, N.K.; Chudasama, A. HPTLC-densitometric method for simultaneous estimation of olmesartan medoxomil and chlorthalidone in tablet dosage form. Anal. Chem. Lett.,  2020, 10(4), 498-506.
 [http://dx.doi.org/10.1080/22297928.2020.1814859]

[69]
Salem, H. Hiqh-perfonnance thin-laver chrornatoaraphv for the determination of certain antihypertensive mixtures. Sci. Pharm.,  2004, 72(2), 157-174.
 [http://dx.doi.org/10.3797/scipharm.aut-04-14]

[70]
Nikalje, A.; Gadikar, R. A simple HPTLC method for simultaneous estimation of atenolol and chlorthalidone in pharmaceuticals. Chem. J.,  2020, 6, 35-47.

[71]
Chaudhary, B.R.; Dave, J.B. Estimation of telmisartan, amlodipine and chlorthalidone in bulk and fixed dose combination using stability indicating high performance thin layer chromatography. Indo Glob. J. Pharm. Sci.,  2020, 2020, 10302.
 [http://dx.doi.org/10.35652/IGJPS.2020.10302]

[72]
Prajapati, P.; Patel, S.; Mishra, A. Simultaneous estimation of azilsartan medoxomil and chlorthalidone by chromatography method using design of experiment and quality risk management based quality by design approach. J. Planar Chromatogr. Mod. TLC,  2020, 33(6), 631-646.
 [http://dx.doi.org/10.1007/s00764-020-00067-4]

[73]
Prajapati, P.; Patel, M.; Shah, S. A robust high-performance thin-layer chromatography method for the simultaneous estimation of chlorthalidone and metoprolol succinate using quality risk assessment and design of experiments-based enhanced analytical quality by design approach. J. Planar Chromatogr. Mod. TLC,  2021, 34(3), 229-242.
 [http://dx.doi.org/10.1007/s00764-021-00107-7]

[74]
Quaglia, M.G.; Farina, A.M.; Fanali, S. Determination of chlorthalidone and its impurities by HPTLC densitometry. J. Chromatogr. A,  1988, 456(2), 435-439.

[75]
Prabhakar, D.; Sreekanth, J.; Jayaveera, K.N. Method development and validatoin of azelnidipine by RP-HPLC. Int. J. Chemtech Res.,  2017, 11(1), 7-12.

[76]
Patel, J.K.; Patel, N.K. Validated stability-indicating RP-HPLC method for the simultaneous determination of azelnidipine and olmesartan in their combined dosage form. Sci. Pharm.,  2014, 82(3), 541-554.
 [http://dx.doi.org/10.3797/scipharm.1312-14] [PMID:  25853066]

[77]
Kumar, M.; Chandra, U.; Garg, A.; Gupta, P. A stability indicating RP-HPLC method validation for simultaneous estimation of azelnidipine and telmisartan in a fixed-dose combination. Int. J. Pharm. Sci. Drug Res.,  2020, 13(3), 288-294.
 [http://dx.doi.org/10.25004/IJPSDR.2021.130308]

[78]
Modi, J.; Patel, S.; Parikh, N.; Shah, S.; Pradhan, P.; Upadhyay, U. Stability indicating analytical method development and validation for estimation of azelnidipine. World J. Pharm. Res.,  2016, 5(2), 831-847.

[79]
Konam, K.; Kanala, S.R.; Pradesh, A. Method development and validation for the simultaneous estimation of azelnidipine and telmisartan in pharmaceutical formulation by high performance liquid chromatography. Bull. Environ. Pharmacol. Life Sci.,  2021, 10, 19-27.

[80]
Kumar, M.; Chandra, U.; Garg, A.; Gupta, P. Impurity profiling of azelnidipine and telmisartan in fixed dose combination using gradient RP-HPLC method. Ann. R.S.C.B.,  2021, 25(4), 15050-15067.

[81]
Gore, M.G.; Dabhade, P.S. RP-HPLC method development and validation of azelnidipine. Int. J. Pharm. Sci. Res.,  2016, 7(12), 5111.
 [http://dx.doi.org/10.13040/IJPSR.0975-8232.7(12).5111-14]

[82]
Jyothi, P.; Geetha, K.; Ajitha, A.; Uma, V.; Rao, M.; Ramarao, N. Stability indicating method development and validation for simultaneous estimation of mefloquine and artesunate in tablet dosage form. (Sch. Acad. J. PharmacyOnline). Sch. Acad. J. Pharm.,  2021, 3(5), 2320-4206.

[83]
Muralidharan, S.; Parasuraman, S.; Venugopal, V. Simple validation of azelnidipine by Rp-Hplc method. Rapp. Pharm.,  2015, 1(1), 43-45.

[84]
Mukthinuthalapati, M.A.; Bukkapatnam, V.; Bandaru, S.P.K. Stability indicating liquid chromatographic method for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations. Adv. Pharm. Bull.,  2014, 4(4), 405-411.
 [http://dx.doi.org/10.5681/apb.2014.060] [PMID:  25436199]

[85]
Kumar, M.; Chandra, U.; Garg, A.; Gupta, P. Development and validation of in-vitro dissolution test using RP-HPLC analysis for simultaneous estimation of azelnidipine and telmisartan in a fixed-dose combination. Res. J. Pharm. Technol.,  2022, 15(5), 1967-1972.
 [http://dx.doi.org/10.52711/0974-360X.2022.00327]

[86]
Giachetti, C.; Tenconi, A.; Canali, S.; Zanolo, G. Simultaneous determination of atenolol and chlorthalidone in plasma by high-performance liquid chromatography application to pharmacokinetic studies in man. J. Chromatogr., Biomed. Appl.,  1997, 698(1-2), 187-194.
 [http://dx.doi.org/10.1016/S0378-4347(97)00298-3] [PMID:  9367207]

[87]
El-Gindy, A.; Sallam, S.; Abdel-Salam, R.A. HPLC method for the simultaneous determination of atenolol and chlorthalidone in human breast milk. J. Sep. Sci.,  2008, 31(4), 677-682.
 [http://dx.doi.org/10.1002/jssc.200700317] [PMID:  18266291]

[88]
Elgawish, M.S.; Mostafa, S.M.; Elshanawane, A.A. Simple and rapid HPLC method for simultaneous determination of atenolol and chlorthalidone in spiked human plasma. Saudi Pharm. J.,  2011, 19(1), 43-49.
 [http://dx.doi.org/10.1016/j.jsps.2010.10.003] [PMID:  23960741]

[89]
Sonawane, S.; Jadhav, S.; Rahade, P.; Chhajed, S.; Kshirsagar, S. Development and validation of stability-indicating method for estimation of chlorthalidone in bulk and tablets with the use of experimental design in forced degradation experiments. Scientifica (Cairo),  2016, 2016, 4286482.
 [http://dx.doi.org/10.1155/2016/4286482] [PMID:  27123364]

[90]
Abdalla, E.; Samia, M.; Mohamed, E. Development and validation of a reversed-phase high-performance liquid chromatographic method for the simultaneous determination of amiloride hydrochloride, atenolol, hydrochlorothiazide, and chlorthalidone in their combined mixtures combined mixtures. Drug Formulat. Clin. Methods,  2009, 92(2), 404-409.

[91]
Kharat, C.; Shirsat, V.A.; Kodgule, Y.M.; Kodgule, M. A validated RP-HPLC stability method for the estimation of chlorthalidone and its process-related impurities in an API and tablet formulation. Int. J. Anal. Chem.,  2020, 2020, 3593805.
 [http://dx.doi.org/10.1155/2020/3593805] [PMID:  32328101]

[92]
El-Gindy, A.; Emara, S.; Mostafa, A. HPLC and chemometric-assisted spectrophotometric methods for simultaneous determination of atenolol, amiloride hydrochloride and chlorthalidone. Farmaco,  2005, 60(3), 269-278.
 [http://dx.doi.org/10.1016/j.farmac.2004.11.013] [PMID:  15784248]

[93]
Kudumula, N.; Rajendra Prasad, Y. Development and validation of Rp-Hplc method for the simultaneous estimation of chlorthalidone and cilnidipine in bulk and combined tablet dosage form. Pharmacophore,  2014, 5(4), 442.

[94]
Muthyala, B.N. Stability indicating Rp-Hplc method development and validation for the determination of naproxen sodium in bulk drug and tablet dosage form. Int. J. Pharm. Qual. Assur.,  2019, 11(4), 525-529.
 [http://dx.doi.org/10.25258/ijpqa.11.4.12]

[95]
Sravani, P.; Rubesh Kumar, S.; Duganath, N.; Devanna, N. Stability indicating method development and validation for the simultaneous estimation of azilsartan medoxomil and chlorthalidone by RP-HPLC in pharmaceutical dosage form. Int. J. Pharm.,  2014, 4(4), 326-332.

[96]
Dangre, P.; Sawale, V.; Meshram, S.; Gunde, M. Development and validation of RP-HPLC method for the simultaneous estimation of eprosartan mesylate and chlorthalidone in tablet dosage form. Int. J. Pharm. Tech. Res.,  2015, 8(2), 163-168.

[97]
Mhaske, R.A.; Sahasrabudhe, S.; Mhaske, A.A. RP-HPLC method for simultataneous determination of irbesartan, losartan, hydro-chlorothiazide and chlorthalidone-application to commercially available drug products. Int. J. Pharm. Sci. Res.,  2012, 3(4), 1116-1123.

[98]
Mhaske, R.; Garole, D.; Mhaske, A. RP-HPLC method for simultataneous determination of amlodipine besylate, valsartan, telmisartan, hydrochlorothiazide and chlorthalidone: Application to commercially available drug products. Int. J. Pharm. Sci. Res.,  2012, 3(03), 793-801.

[99]
Sawale, V.; Dangre, P.; Dhabarde, D. Development and validation of RP-HPLC method for the simulteneous estimation of olmesartan medoxomil and chlorthalidone in tablet dosage form. Int. J. Pharm. Pharm. Sci.,  2015, 7(5), 266-269.

[100]
Hinge, M.A.; Bhanusali, V.M.; Mahida, R.J. Spectrophotometric and high performance liquid chromatographic determination of chlorthalidone and losartan potassium in combined dosage form. Anal. Chem. Lett.,  2016, 6(4), 408-420.
 [http://dx.doi.org/10.1080/22297928.2016.1206834]

[101]
Naazneen, S.; Sridevi, A. Stability-indicating RP-HPLC method for the simultaneous estimation of azilsartan medoxomil and chlorthalidone in solid dosage forms. Int. J. Pharm. Pharm. Sci.,  2014, 6(6), 236-243.

[102]
Jadhav, N.S.; Lalitha, K.G. Estimation of losartan potasium and chlorthalidone in tablet dosage form by RP-HPLC method. World J. Pharm. Res.,  2014, 3(7), 410-419.

[103]
Chaudhary, B.R. Development and validation of stability indicating gradient RP-HPLC method for simultaneous estimation of telmisartan and chlorthalidone in bulk API and fixed dose combination. World J. Pharm. Res.,  2017, 2017, 1015-1029.
 [http://dx.doi.org/10.20959/wjpr201710-9417]

[104]
Reddy, P.S.; Rama, B. Validated stability-indicating HPLC method for simultaneous estimation of olmisartan and chlorthalidone in oral solid form. Am. J. Pharmtech. Res.,  2016, 2016, 98309135.

[105]
Shah, P.; Dhaduk, B. RP-HPLC in-vitro dissolution method development and validation for determination of olmesartan medoxomil, chlorthalidone and cilnidipine drug combinations. Curr. Pharm. Anal.,  2022, 18(6), 629-641.
 [http://dx.doi.org/10.2174/1573412918666220131114138]

[106]
Shaikhmulani, H.; Tamboli, A.; Tamboli, N.; Kshirsagar, R.; Suryawanshi, H.; Khandare, O. RP-HPLC method development and validation for simultaneous estimation of benidipine hydrochloride and chlorthalidone in pharmaceutical dosage form. Indian J. Pharm. Drug Stud.,  2022, 3(2), 6-12.

[107]
El Sayed, A.; Amin, A.; Saad, Z.; Aly, M.; Ahmed, A. Simultaneous determination of azelnidipine and olmesartan medoxomil in pharmaceutical dosage forms by UFLC method. J. Pharm. Sci. Technol.,  2016, 6(2), 2-7.

[108]
Suneetha, G.; Venkateswarlu, P.; Prasad, P.S.S. Sensitive analysis of azelnidipine and related derivative in human plasma by ultra-performance liquid chromatography-tandam mass spectrometry. Asian J. Chem.,  2013, 25(18), 10319-10321.
 [http://dx.doi.org/10.14233/ajchem.2013.15290]

[109]
Kawabata, K.; Samata, N.; Urasaki, Y.; Fukazawa, I.; Uchida, N.; Uchida, E.; Yasuhara, H. Enantioselective determination of azelnidipine in human plasma using liquid chromatography–tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2007, 852(1-2), 389-397.
 [http://dx.doi.org/10.1016/j.jchromb.2007.01.050] [PMID:  17350354]

[110]
Kawabata, K.; Urasaki, Y. Simultaneous determination of azelnidipine and two metabolites in human plasma using liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.,  2006, 844(1), 45-52.
 [http://dx.doi.org/10.1016/j.jchromb.2006.06.031] [PMID:  16854634]

[111]
Amin, M.A.; Amin, A.S.; Saad, M.Z. Stability indicating ultra-fast liquid chromatography coupled with photodiode array method for simultaneous estimation of azelnidipine and olmesartan medoxomil in pharmaceutical formulations. J. Pharm. Sci. Technol.,  2020, 9(1), 9-14.
 [http://dx.doi.org/10.33981/JPST.2020.v09i01.002]

[112]
Gao, Y.; Li, B.; Zhu, B.; Liu, D.; Zhao, H.; Fang, Z.; Wang, H.; Lou, H. A liquid chromatography-tandem mass spectrometric assay for the antihypertensive agent azelnidipine in human plasma with application to clinical pharmacokinetics studies. Biomed. Chromatogr.,  2015, 29(7), 970-974.
 [http://dx.doi.org/10.1002/bmc.3399] [PMID:  25472837]

[113]
Sun, L.; Zhu, G.; Yan, X.; Champion, M.M.; Dovichi, N.J. Capillary zone electrophoresis for analysis of complex proteomes using an electrokinetically pumped sheath flow nanospray interface. Proteomics,  2014, 14(4-5), 622-628.
 [http://dx.doi.org/10.1002/pmic.201300295] [PMID:  24277677]

[114]
Ruiz-Angel, M.J.; Peris-García, E.; García-Alvarez-Coque, M.C. Reversed-phase liquid chromatography with mixed micellar mobile phases of Brij-35 and sodium dodecyl sulphate: A method for the analysis of basic compounds. Green Chem.,  2015, 17(6), 3561-3570.
 [http://dx.doi.org/10.1039/C5GC00338E]

[115]
Dadgar, D.; Kelly, M.T. Determination of chlorthalidone in human plasma by reversed-phase micellar liquid chromatography. Analyst (Lond.),  1988, 113(8), 1223-1227.
 [http://dx.doi.org/10.1039/an9881301223] [PMID:  3232833]

[116]
Al Azzam, K.; Elbashir, A.A.; Elbashir, M.A.; Saad, B.; Abdul Hamid, S. Simultaneous determination of atenolol and chlorthalidone in pharmaceutical preparations by capillary-zone electrophoresis. Anal. Lett.,  2009, 42(10), 1458-1470.
 [http://dx.doi.org/10.1080/00032710902961065]

[117]
Al Azzam, K.M.; Saad, B.; Aboul-Enein, H.Y. Simultaneous determination of atenolol, chlorthalidone and amiloride in pharmaceutical preparations by capillary zone electrophoresis with ultraviolet detection. Biomed. Chromatogr.,  2010, 24(9), 1395.
 [http://dx.doi.org/10.1002/bmc.1395] [PMID:  20066730]

[118]
Fleuren, H.L.J.M. Rossum, ; Van, J.M. Determination of chlorthalidone in plasma, urine and red blood cells by gas chromatography with nitrogen detection. 1978, 152, 41-54.
Rights & Permissions Print Cite
Journal Information
For Authors
For Editors
For Reviewers
Explore Articles
Open Access
Open Access Articles
For Visitors
DOI https://dx.doi.org/10.2174/1573412919666221025124218	Print ISSN 1573-4129
Publisher Name Bentham Science Publisher	Online ISSN 1875-676X
Current Pharmaceutical Analysis

Progress in Quantitative Methods for Azelnidipine and Chlorthalidone: An Analytical Basis for a Recently Approved FDC

Abstract Play Pause

Graphical Abstract

Related Journals

Related Books

Abstract
