Abstract
Background: Smart different stability-indicating spectrophotometric methods have been established for the assay of chlordiazepoxide and clidinium bromide without the intervention of alkaline degradate of clidinium via various and different manipulating pathways without previous separation steps.
Objective: The specificity of the established methods was inspected by analysing mixtures of cited drugs in the existence of the alkali-induced degradation product.
Methods: These methods were employed either on scanned zero-order absorption spectra using absorbance subtraction, dual wavelength and Q-absorbance ratio or the amplitudes of the ratio spectra of zero-order absorption spectra like amplitude modulation and by derivative techniques to the ratio spectra as a derivative ratio method. In addition, the absorbance of the recovered zero-order absorption spectra was applied by successive ratio subtraction coupled with constant multiplication. Finally, the pathway depends on the amplitudes of the derivative spectra, successive derivative subtraction coupled with constant multiplication. The ranges of linearity were (1-12µg/mL) for chlordiazepoxide and (3- 12µg/mL) for clidinium bromide.
Results: The outcomes achieved by the prospective methods were in consent with those of the official and reported methods when statistically compared using student’s t test, F-test and one-way ANOVA where no significant difference was detected with suitable precision, proving the absence of any important difference in accuracy and precision between them. They were confirmed in accordance with International Conference on Harmonization guidelines.
Conclusion: The established methods can be considered as alternative methods for the routine determination of this fixed dose combination with minimum sample preparation.
Keywords: Stability-indicating, absorbance subtraction, amplitude modulation, successive derivative subtraction, dual wavelength, Q-absorbance ratio, chlordiazepoxide and clidinium bromide.
Graphical Abstract
[1]
Mcevory, G.K. AHFS Drug Information; (Ed.), American Society of Hospital Pharmacists,. , 1990, pp. 1256-1256.
[2]
Rudy, B.C.; Senkowski, B.Z. Analytical Profiles of Drug Substances; Vol. 2, K. Florey (Ed.), Academic Press, New York, NY,USA,. , 1973, pp. 145-161.
[3]
Brunton, L.L.; Lazo, J.S.; Parker, K.L. Goodman and Gilman’s the Pharmacological Basis of Therapeutics; 11th Ed., McGraw-Hill Book Co., New York,. , 2006. NY.
[4]
Mcevory, G.K. AHFS Drug Information (Ed.), American Society of Health-System Pharmacists,. , 2008; pp. 2582-2583.
[5]
Walash, M.I.; Rizk, M.; El-Brash, A.M. Spectrophotometric determination of chlordiazepoxide and nitrazepam. Talanta, 1988, 35(11), 895-898.
[6]
Patel, S.; Patel, N.J. Spectrophotometric and chromatographic simultaneous estimation of amitriptyline hydrochloride and chlordiazepoxide in tablet dosage forms. Indian J. Pharm. Sci., 2009, 71(4), 472-476.
[7]
Lotfy, H.M.; Fayez, Y.M.; Michael, A.M.; Nessim, C.K. Simultaneous determination of mebeverine hydrochloride and chlordiazepoxide in their binary mixture using novel univariate spectrophotometric methods via different manipulation pathways. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2016, 155, 11-20.
[8]
British Pharmacopoeia In: The Stationery Office on Be- half of the Medicines and Healthcare Products Regulatory Agency; Vol. I & II(MHRA). , 2013.
[9]
El-Sayed, G.O.; Yasin, S.A.; El-Badawy, A.A. Adsorptive voltammetric determination of chlordiazepoxide in pure and dosage forms. J. Chem. Pharm. Res., 2009, 1(1), 225-232.
[10]
Sun, S.R. Quantitative determination of chlordiazepoxide and its metabolites in serum by fluorescence TLC-densitometry. J. Pharm. Sci., 1978, 67(5), 639-641.
[11]
Lotfy, H.M.; Fayez, Y.M.; Michael, A.M.; Nessim, C.K. Comparative study of the resolution efficiency of HPLC and HPTLC-densitometric methods for the analysis of mebeverine hydrochloride and chlordiazepoxide in their binary mixture. Eur. J. Chem., 2016, 7(3), 315-321.
[12]
Nickerson, B. The determination of a degradation product in clidinium bromide drug substance by capillary electrophoresis with indirect UV detection. J. Pharm. Biomed. Anal., 1997, 15(7), 965-971.
[13]
Authority of the U.S. Pharmacopeial Convention 2011. U.S.Pharmacopeia (USP 34), Rockville, Md, USA
[14]
Toral, M.I.; Richter, P.; Lara, N.; Jaque, P.; Soto, C.; Saavedra, M. Simultaneous determination of chlordiazepoxide and clidinium bromide in pharmaceutical formulations by derivative spectrophotometry. Int. J. Pharm., 1999, 189(1), 67-74.
[15]
Yuen, S.M.; Lehr, G. Liquid chromatographic determination of clidinium bromide and clidinium bromide-chlordiazepoxide hydrochloride combinations in capsules. J. AOAC Int., 1991, 74(3), 461-464.
[16]
Pathak, A.; Rai, P.; Rajput, S.J. Stability-Indicating HPLC method for simultaneous determination of clidinium bromide and chlordiazepoxide in combined dosage forms. J. Chromatogr. Sci., 2010, 48(3), 235-239.
[17]
Jalal, I.M.; Sa’sa, S.I.; Hussein, A.; Khalil, H.S. Reverse-phase high performance liquid chromatographic determination of clidinium bromide and chlordiazepoxide in tablet formulations. Anal. Lett., 1987, 20(4), 635-655.
[18]
Ashour, S.; Kattan, N. simultaneous determination of clidinium bromide and chlordiazepoxide in combined dosage forms by high-performance liquid chromatography. J. Pharm. , 2013, 2013, 1-7.
[19]
Khoshay, M.R.; Abdollahi, H.; Moeini, A.; Shamsaie, A.; Ghaffari, A.; Abbasian, S. Simultaneous spectrophotometric determination of chlordiazepoxide and clidinium using multivariate calibration techniques. Drug Test. Anal., 2010, 2(9), 430-435.
[20]
ICH , Guideline Stability Testing of New Drug Substances and Products Q1A International Conference on Harmonization, Geneva, Switzerland1993.
[21]
Bosch-Reig, F.; Compins-Falco, P. H-point standard additions method. Part 1. Fundamentals and application to analytical spectroscopy. Analyst , 1988, 113, 1011-1016.
[22]
Verdu-Andres, J.; Bosch-Reig, F.&; Compins-Falco, P. H-point standard additions method for analyte determination in ternary mixtures. Analyst , 1995, 120, 299-304.
[23]
Salinas, F.; Nevado, J.J.B.; Espinosa Mansilla, A. A new spectrophotometric method for quantitative multicomponent analysis resolution of mixtures of salicylic and salicyluric acids. Talanta, 1990, 37, 347-351.
[24]
Nevado, J.J.B.; Guiberteau, C.C.; Contento Salcedo, A.M. Simultaneous spectrophotometric determination of three food dyes by using the first derivative of ratio spectra. Talanta, 1995, 42, 2043-2051.
[25]
Onur, F.; Yucesoy, C.; Dermis, S.; Katral, M.; Kukdil, G. Simultaneous determination of pseudoephedrine sulfate, dexbrompheniramine maleate and loratadine in pharmaceutical preparations using derivative spectrophotometry and ratio spectra derivative spectrophotometry. Talanta, 2000, 51, 269-279.
[26]
Dinc, E.; Yucesoy, C.; Onur, F. Simultaneous spectrophotometric determination of mefenamic acid and paracetamol in a pharmaceutical preparation using ratio spectra derivative spectrophotometry and chemometric methods. J. Pharm. Biomed. Anal., 2002, 28, 1091-1100.
[27]
Dinc, E.; Onur, F. Application of a new spectrophotometric method for the analysis of a ternary mixture containing metamizol, paracetamol and caffeine in tablets. Anal. Chim. Acta, 1998, 356, 93-106.
[28]
Wold, S.; Sjostrom, M.; Eriksson, L. PLS-regression: a basic tool of chemometrics. Chemom. Intell. Lab. Syst., 2001, 58(2), 109-130.
[29]
Blanco, M.; Gene, J.; Iturriaga, H.; Maspoch, S.; Riba, J. Diode-array detectors in flow-injection analysis Mixture resolution by multi-wavelength analysis. Talanta, 1987, 34, 987-993.
[30]
Al-Arfaj, N.; Al-Onazi, W.; Al-Brashy, A. Spectrophotometric bivariate method for determination of candesartan cilexetil in presence of its alkaline induced degradation product. Asian J. Chem., 2013, 25(2), 719-725.
[31]
López-de-Alba, P.L.; Wróbel, K.; López-Martínez, L.; Yepez-Murrieta, M.L. Amador-Hernández, Application of the bivariate spectrophotometric method for the determination of metronidazole, furazolidone and di-iodohydroxyquinoline in pharmaceutical formulations. J. Pharm. Biomed. Anal., 1997, 16(2), 349-355.
[32]
Shetty, P.R.; Patil, D.D. Applications of simultaneous equation method and derivative method for the determination of rabeprazole sodium and levosulpiride in pharmaceutical dosage form and dissolution samples, J. Assoc. Arab Univ. Basic Appl. Sci., 2014, 15, 53-60.
[34]
Hirt, R.C.; King, F.T.; Schmitt, R.G. Graphical absorbance-ratio method for rapid two-component spectrophotometric analysis. Anal. Chem., 1954, 26(8), 1270-1273.http://sci-hub.bz/10.1021/ac60092a004
[35]
Oza, C.K.; Nijhawan, R.; Pandya, M.K.; Vyas, A.J.; Patel, A.I. Q-Analysis Spectrophotometric method for the simultaneous determination of Nabumetone and Paracetamol in API and in tablet dosage form. Asian J. Pharmaceut. Anal., 2013, 3(1), 9-16.
[36]
Lotfy, H.M.; Tawakkol, S.M.; Fahmy, N.M.; Shehata, M.A. Successive spectrophotometric resolution as a novel technique for the analysis of ternary mixtures of pharmaceuticals. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2014, 121, 313-323.
[37]
Lotfy, H.M.; Hegazy, M.A.; Rezk, M.R.; Omran, Y.R. Novel spectrophotometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2014, 126, 197-207.
[38]
Lotfy, H.M. Absorbance subtraction and amplitude modulation as novel spectrophotometric methods for the analysis of binary mixtures. Int. J. Pharm. Pharm. Sci., 2014, 6(1), 735-741.
[39]
Lotfy, H.M.; Saleh, S.S.; Hassan, N.Y.; Salem, H. A comparative study of novel spectrophotometric methods based on isosbestic points; application on a pharmaceutical ternary mixture. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2014, 126, 112-121.
[40]
Samir, A.; Salem, H. Abd El-kawy, M. New developed spectrophotometric method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in bulk powder and Seritide® diskus inhalation. Pharm. Acta, 2012, 50(2), 121-126.
[41]
Erram, V.S.; Tipnis, H.P. Simple spectrometric analysis of acebutolol hydrochloride and atenolol in combined pharmaceutical dosages with hydrochlorothiazide. Indian Drugs, 1993, 30(9), 462-467.
[42]
Lotfy, H.M.; Hegazy, M.A.; Rezk, M.R.; Omran, Y.R. Comparative study of novel versus conventional two-wavelength spectrophotometric methods for analysis of spectrally overlapping binary mixture. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2015, 148, 328-337.
[43]
Lotfy, H.M.; Hegazy, M.A. Simultaneous determination of some cholesterol-lowering drugs in their binary mixture by novel spectrophotometric methods. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2013, 113, 107-114.
[44]
Patel, C.V.; Khandhar, A.P.; Captain, A.D.; Patel, K.T. Validated absorption factor spectrophotometric and reversed-phase high-performance liquid chromatographic methods for the determination of ramipril and olmesartan medoxomil in pharmaceutical formulations. Eurasian J. Anal. Chem., 2007, 2(3), 159-171.
[45]
Afkhami, A.; Bahram, M. Successive ratio-derivative spectra as a new spectrophotometric method for the analysis of ternary mixtures. Spectrochim. Acta A Mol. Biomol. Spectrosc., 2005, 61(5), 869-877.
[46]
Lotfy, H.M.; Saleh, S.S.; Hassan, N.Y.; El-Gizawy, S.M. A comparative study of spectrophotometric methods versus chemometric methods; an application on a pharmaceutical binary mixture of ofloxacin and dexamethasone. Am. J. Anal. Chem., 2012, 3, 761-769.
[47]
Abd El-Wahab, N.S. Spectrophotometric methods for simultaneous determination of Carvedilol and Hydrochlorothiazide in combined dosage form. Arab. J. Chem., 2016, 9(1), 355-360.
[48]
Siddiqui, M.R.; AlOthman, Z.A.; Rahman, N. Analytical techniques in pharmaceutical analysis: A review. Arab. J. Chem., 2017, 10, 1409-1421.
[49]
Leung, C.H.; Zhong, H.; Yang, H.; Cheng, Z.; Chan, D.Sh.; Ma, V.P.; Abagyan, R.; Wong, Ch.; Ma, D.L. A metal‐based inhibitor of tumor necrosis factor‐α. Angew. Chem. Int. Ed., 2012, 51(36), 9010-9014.
[50]
Ma, D.L.; He, H.Z.; Leung, K.; Chan, D.Sh.; Leung, C.H. Bioactive luminescent transition‐metal complexes for biomedical applications. Angew. Chem. Int. Ed., 2013, 52, 7666-7682.
[51]
Lotfy, H.M.; Fayez, Y.M.; Michael, A.M.; Nessim, C.K. Validated stability-indicating chromatographic methods for the determination of chlordiazepoxide and clidinium bromide in the presence of its alkali-induced degradation product: kinetic study. Chromatographia, 2017, 80(6), 911-922.
[52]
Lotfy, H.M.; Fayez, Y.M.; Michael, A.M.; Nessim, C.K. Novel stability-indicating chemometric-assisted spectrophotometric methods for the determination of chlordiazepoxide and clidinium bromide in the presence of clidinium bromide’s alkali-induced degradation product. J. AOAC Int., 2018, 101(3), 714-722.
Article Metrics
4