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Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Review Article

Advancements in the Analytical Methods for Ripasudil Hydrochloride Hydrate and Timolol Maleate: A Recently Approved FDC

Author(s): Khushbu Patel and Rajendra Kotadiya*

Volume 19, Issue 6, 2023

Published on: 08 August, 2023

Page: [487 - 496] Pages: 10

DOI: 10.2174/1573412919666230807114942

Price: $65

Abstract

Fixed-dose Combinations (FDCs) combine two or more medications into a single dosage form. Several benefits, including impending therapeutic efficacy, a decline in episodes of adverse drug effects, pharmacokinetic advantages, a decrease in pill burden, a reduction in the dose of individual medications, and a reduction in the emergence of drug resistance, justify their acceptance. For the treatment of increased Intraocular Pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension, an FDC eye drop formulation, including ripasudil hydrochloride hydrate (0.4%W/V) and timolol maleate (0.5%W/V) has just received approval. No analytical method has been reported thus far for this newly approved combination. Thus, this review collected and simplified information on reported analytical techniques and physicochemical and biological properties for the above-cited FDCs. The authors have explored various authenticated scientific journals and presented simplified information to meet the objectives. In this study, the reported methods are spectroscopy (nil, 23%), HPTLC (nil, 10%), HPLC (100%, 61%), hyphenated techniques (nil, 6%) and electrophoresis methods (nil, 6%) for ripasudil hydrochloride hydrate and timolol maleate, respectively. Analysts using such comprehensive data might develop a method for analyzing the recently approved FDCs.

Graphical Abstract

[1]
Shah, J.; Kotadiya, R. A critical review on analytical methods for recently approved fdc drugs: Pregabalin and etoricoxib. Crit. Rev. Anal. Chem., 2022, 52(5), 1048-1068.
[http://dx.doi.org/10.1080/10408347.2020.1855411] [PMID: 33307732]
[2]
Garnock-Jones, K.P. Ripasudil, First global approval. drugs, 2014, 74(18), 2211-2215.
[http://dx.doi.org/10.1007/s40265-014-0333-2]
[3]
Dunn, F.G.; Frohlich, E.D. Pharmacokinetics, mechanisms of action, indications, and adverse effects of timolol maleate, a nonselective beta-adrenoreceptor blocking agent. Pharmacotherapy, 1981, 1(3), 188-200.
[http://dx.doi.org/10.1002/j.1875-9114.1981.tb02540.x] [PMID: 6765488]
[4]
Kotadiya, R.; Joshi, P. Progress in analytical techniques for remogliflozin etabonate, vildagliptin and metformin hydrochloride: a recently, approved fDC. Curr. Pharm. Anal., 2023, 19(2), 136-162.
[http://dx.doi.org/10.2174/1573412919666221025103613]
[5]
Ripasudil hydrochloride hydrate. Available From: https://pubchem.ncbi.nlm.nih.gov/compound/Ripasudil
[6]
[7]
Kusuhara, S.; Nakamura, M. Ripasudil hydrochloride hydrate in the treatment of glaucoma : Safety , ef fi cacy , and patient selection Clin. opthalmolgy., 2020, 14, 1229-1236.
[8]
Inoue, T.; Tanihara, H. Ripasudil hydrochloride hydrate: Targeting rho kinase in the treatment of glaucoma. Expert Opin. Pharmacother., 2017, 18(15), 1669-1673.
[http://dx.doi.org/10.1080/14656566.2017.1378344] [PMID: 28893104]
[9]
Ohta, Y.; Takaseki, S.; Yoshitomi, T. Effects of ripasudil hydrochloride hydrate (k-115), a rho-kinase inhibitor, on ocular blood flow and ciliary artery smooth muscle contraction in rabbits. Jpn. J. Ophthalmol., 2017, 61(5), 423-432.
[http://dx.doi.org/10.1007/s10384-017-0524-y] [PMID: 28653193]
[10]
Yasuda, M.; Takayama, K.; Kanda, T.; Taguchi, M.; Someya, H.; Takeuchi, M. Comparison of intraocular pressure-lowering effects of ripasudil hydrochloride hydrate for inflammatory and corticosteroid-induced ocular hypertension. PLoS One, 2017, 12(10), e0185305.
[http://dx.doi.org/10.1371/journal.pone.0185305] [PMID: 28968412]
[11]
Kaneko, Y.; Ohta, M.; Inoue, T.; Mizuno, K.; Isobe, T.; Tanabe, S.; Tanihara, H. Effects of K-115 (Ripasudil), a novel ROCK inhibitor, on trabecular meshwork and Schlemm’s canal endothelial cells. Sci. Rep., 2016, 6(1), 19640.
[http://dx.doi.org/10.1038/srep19640] [PMID: 26782355]
[12]
Neufeld, A.H. Experimental studies on the mechanism of action of timolol. Surv. Ophthalmol., 1979, 23(6), 363-370.
[http://dx.doi.org/10.1016/0039-6257(79)90229-7] [PMID: 223248]
[13]
Zimmerman, T.J.; Boger, W.P., III The beta-adrenergic blocking agents and the treatment of glaucoma. Surv. Ophthalmol., 1979, 23(6), 347-362.
[http://dx.doi.org/10.1016/0039-6257(79)90228-5] [PMID: 37605]
[14]
Hui, W.; Sun, L.; Zhang, H.; Zou, L.; Zou, Q.; Ouyang, P. Quantitative analysis of ripasudil hydrochloride hydrate and its impurities by reversed-phase high-performance liquid chromatography after precolumn derivatization: Identification of four impurities. J. Sep. Sci., 2016, 39(17), 3302-3310.
[http://dx.doi.org/10.1002/jssc.201600278] [PMID: 27390135]
[15]
Olah, T.V.; Gilbert, J.D.; Barrish, A. Determination of the β-adrenergic blocker timolol in plasma by liquid chromatography—atmospheric pressure chemical ionization mass spectrometry. J. Pharm. Biomed. Anal., 1993, 11(2), 157-163.
[http://dx.doi.org/10.1016/0731-7085(93)80136-O] [PMID: 8504187]
[16]
Maguregui, M.I.; Jiménez, R.M.; Alonso, R.M.; Akesolo, U. Quantitative determination of oxprenolol and timolol in urine by capillary zone electrophoresis. J. Chromatogr. A, 2002, 949(1-2), 91-97.
[http://dx.doi.org/10.1016/S0021-9673(01)01320-6] [PMID: 11999762]
[17]
Ivanković A.; Dronjic, A.; Bevanda, A.M. Review of 12 principles of green chemistry in practice. Int. J. Sustain. Green Energy, 2017, 6(3), 39-48.
[http://dx.doi.org/10.11648/j.ijrse.20170603.12]
[18]
Wahid, M.; Ahmad, F.; Ahmad, N. Green chemistry : Principle and its application. In: In Green Chemistry : Principle and its Application:; , 2017; p. 395-399.
[19]
Matlack, A.S. Introduction to green chemistry; CRC Press: Boca Raton, 2010, p. 648.
[http://dx.doi.org/10.1201/9781439882115]
[20]
Tambe, S.; Jain, D.; Amin, P. Simultaneous determination of dorzolamide and timolol by first-order derivative uv spectroscopy in simulated biological fluid for in vitro drug release testing. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2021, 255, 119682.
[http://dx.doi.org/10.1016/j.saa.2021.119682] [PMID: 33770736]
[21]
Salem, H.; Aboulkheir, A.; Aziz, B.E.A. Development and validation of novel spectro- chemometric, chemometric and tlc-densitometric methods for simultaneous determination of timolol and travoprost in their bulk powders and pharmaceutical formulation. Arch. Pharm. Res., 2019, 2(1), 1-11.
[http://dx.doi.org/10.33552/APPR.2019.02.000527]
[22]
Valizadeh, M.; Sohrabi, M.R.; Motiee, F. Spectrochimica acta part a  Molecular and biomolecular spectroscopy the application of continuous wavelet transform based on spectrophotometric method and high-performance liquid chromatography for simultaneous determination of anti-glaucoma drugs in eye. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2020, 242, 118777.
[http://dx.doi.org/10.1016/j.saa.2020.118777] [PMID: 32801022]
[23]
Mathrusri Annapurna, M.; Sushmitha, M.; Sevyatha, V.S.V. Simultaneous determination of brimonidine tartrate and timolol maleate by first derivative and ratio derivative spectroscopy. J. Anal. Pharm. Res., 2017, 4(6), 12-14.
[http://dx.doi.org/10.15406/japlr.2017.04.00120]
[24]
Nnadi, C.O.; Obonga, W.O.; Ogbonna, J.D.N.; Ugwu, L.O. Development of vanadometric system for spectrophotometric determination of timolol in pure and dosage forms. Trop. J. Pharm. Res., 2016, 14(12), 2223-2229.
[http://dx.doi.org/10.4314/tjpr.v14i12.11]
[25]
Bebawy, L.I. Application of tlc-densitometry, first-derivative uv-spectrophotometry and ratio derivative spectrophotometry for the determination of dorzolamide hydrochloride and timolol maleate. J. Pharm. Biomed. Anal., 2002, 27(5), 737-746.
[http://dx.doi.org/10.1016/S0731-7085(01)00529-5] [PMID: 11814715]
[26]
Desai, H.; Captain, A. Three simple validated UV spectrophotometric methods for the simultaneous estimation of timolol maleate and brimonidine tartrate and their comparison using ANOVA. Int. J. Pharm. Res. Anal., 2014, 4(3), 168-177.
[27]
Kulkarni, S.P.; Amin, P.D. Stability indicating hptlc determination of timolol maleate as bulk drug and in pharmaceutical preparations. J. Pharm. Biomed. Anal., 2000, 23(6), 983-987.
[http://dx.doi.org/10.1016/S0731-7085(00)00389-7] [PMID: 11095299]
[28]
Boiero, C.; Allemandi, D.; Longhi, M.; Llabot, J.M. RP-HPLC method development for the simultaneous determination of timolol maleate and human serum albumin in albumin nanoparticles. J. Pharm. Biomed. Anal., 2015, 111, 186-189.
[http://dx.doi.org/10.1016/j.jpba.2015.03.031] [PMID: 25890214]
[29]
Erk, N. Rapid and sensitive hplc method for the simultaneous determination of dorzolamide hydrochloride and timolol maleate in eye drops with diode- array and uv detection. Pharmazie, 2003, 58, 491-493.
[30]
Nasir, F.; Iqbal, Z.; Khan, A.; Ahmad, L.; Shah, Y.; Khan, A.Z.; Khan, J.A.; Khan, S. Simultaneous determination of timolol maleate, rosuvastatin calcium and diclofenac sodium in pharmaceuticals and physiological fluids using hplc-uv. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2011, 879(30), 3434-3443.
[http://dx.doi.org/10.1016/j.jchromb.2011.09.021] [PMID: 21963479]
[31]
Abd-AlGhafar, W.N.; Aly, F.A.; Sheribah, Z.A.; Saad, S. Green HPLC method with time programming for the determination of the co-formulated eye drops of tafluprost and timolol in their challengeable ratio. BMC Chem., 2022, 16(1), 28.
[http://dx.doi.org/10.1186/s13065-022-00815-z] [PMID: 35440055]
[32]
Walash, M.; El-Shaheny, R. Fast separation and quantification of three anti-glaucoma drugs by high-performance liquid chromatography UV detection. J. Food Drug Anal., 2016, 24(2), 441-449.
[http://dx.doi.org/10.1016/j.jfda.2015.11.006] [PMID: 28911600]
[33]
Mohamed, A.M.I.; Abdel-Wadood, H.M.; Mousa, H.S. Simultaneous determination of dorzolomide and timolol in aqueous humor: A novel salting out liquid–liquid microextraction combined with HPLC. Talanta, 2014, 130, 495-505.
[http://dx.doi.org/10.1016/j.talanta.2014.06.074] [PMID: 25159439]
[34]
Naik, S.; Mullick, P.; Mutalik, S.P.; Hegde, A.R.; Lewis, S.A.; Bhat, K.; Rao, B.S.S.; Mutalik, S. Full factorial design for development and validation of a stability-indicating rp-hplc method for the estimation of timolol maleate in surfactant-based elastic nano-vesicular systems. J. Chromatogr. Sci., 2022, 60(6), 584-594.
[http://dx.doi.org/10.1093/chromsci/bmab101] [PMID: 34435614]
[35]
Shahzad, A.; Arshad, S.; Zubair, F.; Shahzad, S.; Batool, F.; Fu, Q. Development and validation of facile rp-hplc method for simultaneous determination of timolol maleate, moxifloxacin hydrochloride, diclofenac sodium and dexamethasone in plasma, aqueous humor and pharmaceutical products. J. Chromatogr. Sci., 2022, 24, bmac057.
[36]
Marley, A.; Connolly, D. Determination of (r)-timolol in (s)-timolol maleate active pharmaceutical ingredient: Validation of a new supercritical fluid chromatography method with an established normal phase liquid chromatography method. J. Chromatogr. A, 2014, 1325, 213-220.
[http://dx.doi.org/10.1016/j.chroma.2013.12.011] [PMID: 24377734]
[37]
Baker, M.M.; Belal, T.S. Validated hplc–dad method for the simultaneous determination of six selected drugs used in the treatment of glaucoma. J. AOAC Int., 2018, 101(4), 993-1000.
[http://dx.doi.org/10.5740/jaoacint.16-0439] [PMID: 28859698]
[38]
Ibrahim, F.A.; Elmansi, H.M.; El Abass, S.A. A versatile hplc method with an isocratic single mobile phase system for simultaneous determination of anti-glaucoma formulations containing timolol. Ann. Pharm. Fr., 2019, 77(4), 302-312.
[http://dx.doi.org/10.1016/j.pharma.2019.02.005] [PMID: 31027754]
[39]
Ankit, A.; Sunil, T.; Kashyap, N. Research article method development and its validation for quantitative simultaneous determination of latanoprost. J. Drug Deliv. Ther., 2013, 3(2), 26-30.
[40]
Mehta, J.; Patel, V.; Kshatri, N.; Vyas, N. A versatile LC method for the simultaneous quantification of latanoprost, timolol and benzalkonium chloride and related substances in the presence of their degradation products in ophthalmic solution. Anal. Methods, 2010, 2(11), 1737-1744.
[http://dx.doi.org/10.1039/c0ay00405g]
[41]
Rizk, M.S.; Merey, H.A.; Tawakkol, S.M.; Sweilam, M.N. Development and validation of a stability-indicating micellar liquid chromatographic method for the determination of timolol maleate in the presence of its degradation products. J. Chromatogr. Sci., 2015, 53(4), 503-510.
[http://dx.doi.org/10.1093/chromsci/bmu075] [PMID: 25013029]
[42]
Gallegos, A.; Peavy, T.; Dixon, R.; Isseroff, R.R. Development of a novel ion-pairing UPLC method with cation-exchange solid-phase extraction for determination of free timolol in human plasma. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2018, 1096, 228-235.
[http://dx.doi.org/10.1016/j.jchromb.2018.08.016] [PMID: 30189376]
[43]
Sharma, N.; Rao, S.S.; Reddy, A.M. A novel and rapid validated stability-indicating UPLC method of related substances for dorzolamide hydrochloride and timolol maleate in ophthalmic dosage form. J. Chromatogr. Sci., 2012, 50(9), 745-755.
[http://dx.doi.org/10.1093/chromsci/bms025] [PMID: 22562819]
[44]
Büker, E.; Dinç, E. A new uplc method with chemometric design – optimization approach for the simultaneous quantitation of brimonidine tartrate and timolol maleate in an eye drop preparation. J. Chromatogr. Sci., 2016, 1-8.
[http://dx.doi.org/10.1093/chromsci/bmw160] [PMID: 27881494]
[45]
Head, M. Design of experiment utilization to develop a simple and robust rp-uplc method for stability indicating method of anti glaucoma ophthalmic drops design of experiment utilization to develop a simple and robust rp- uplc method for stability indicating method, 2017.

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