UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS QUANTITATIVE ESTIMATION OF MEBEVERINE HYDROCHLORIDE AND CHLORDIAZEPOXIDE IN CAPSULES
Keywords:
UV, Mebeverine hydrochloride, Chlordiazepoxide, Method development, ValidationAbstract
Objective: To develop a simple and cheap UV spectrophotometric method for the simultaneous quantitative estimation of Mebeverine hydrochloride (135mg) and Chlordiazepoxide (5mg) in MEVA C Capsules and validate as per ICH guidelines.
Methods: The optimized method uses a diluent 100% Triethylammonium phosphate buffer (pH 3.0) for the estimation of assay of Mebeverine hydrochloride and Chlordiazepoxide in Capsules which are analyzed at a detection wavelength of 260nm.
Results: The developed method exhibited linearity in the range of 10-40μg/ml for Mebeverine hydrochloride and 2.5-10μg/ml for Chlordiazepoxide. The precision for Mebeverine hydrochloride and Chlordiazepoxide is exemplified by relative standard deviation of 0.499% and 1.75 respectively. Percentage Mean recovery for Mebeverine hydrochloride and Chlordiazepoxide were found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 321ng/ml and 3.7ng/ml respectively, while limit of quantitiation (LOQ) for Mebeverine hydrochloride and Chlordiazepoxide were found to be 973ng/ml and 11.2ng/ml respectively.
Conclusion: A simple and a cheap UV spectrophotometric method was developed and validated for the simultaneous quantitative estimation of Mebeverine hydrochloride and Chlordiazepoxide in capsules as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries.
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References
Arayne MS, Sultana N, Siddiqui FA. A new RPHPLC method for analysis of mebeverine hydrochloride in raw materials and tablets. Pak J Pharm Sci 2005;18(2):11-4.
Walash MI, Sharaf El-din MMK, El-enany NM, Eid MI, Shalan SM. Simultaneous determination of sulpiride and mebeverine by HPLC method using fluorescence detection:application to real human plasma. J Chem Cent 2012;6(13):1-12.
Souri E, Aghdami AN, Adib N. A stability indicating HPLC method for determination of mebeverine in the presence of its degradation products and kinetic study of its degradation in oxidative condition. J Res Pharm Sci 2014;9(3):199-206.
Gupta SP, Upmanyu N, Garg G. Development and validation of spectrophotometric, HPTLC and HPLC methods for the determination of Imipramine and Chlordiazepoxide in pharmaceutical dosage forms. J Der Pharmacia Sinica 2012;3(2):185-92.
Sujatha N, Pavani KH. Analytical method development and validation of amitriptyline hydrochloride and chlordiazepoxide in tablet by RP-HPLC. Indian J of Res in Pharmacy and Biotechnology 2013;1(5):655-9.
De Schutter JA, De Croo F, Vander Weken G, Venden Bossche W, De Moerloose P. Stability study and quantitative determination of mebeverine hydrochloride in tablets by means of reversed-phase high-performance liquid chromatography. J Chromatographia 1985;20:185-92.
7.Al-Deeb Q, Al-Hadiya BM, Foda NH. Quantitative analysis of mebeverine in dosage forms by HPLC. J Chromatographia 1997;44:427-30.
Dubois JG, Atassi G, Hanocq M. High-performance liquid chromatographic determination of chlordiazepoxide, its metabolises and oxaziridines generated after UV irradiation. J Chromatogr A 1994;662(2):255-62.
Roberts SE, Delaney MF. Determination of chlordiazepoxide, its hydrochloride and related impurities in pharmaceutical formulations by reversed-phase high-performance liquid chromatography. J Chromatogr 1984;283:265-72.
Greizerstein HB, Mclaughlin IG. The High-Pressure Liquid Chromatographic Determination of Chlordiazepoxide and Its N-Demethyl Metabolite in Mouse Brain. J Liq Chromatogr 1980;3(7):1023-30.
Puglisi CV, Desilva JAF. Determination of Chlordiazepoxide and Its Metabolites in Plasma by High Pressure Liquid Chromatography. J Anal Lett 1978;11(2):135-60.
Kohlhof K. Determination of chlordiazepoxide in mouse plasma by gas chromatography— negative-ion chemical ionization mass spectrometry. J Chromatogr B Biomed Appl 1994;660(1):95-101.
Sun SR. Quantitative determination of chlordiazepoxide and its metabolites in serum by fluorescence TLC-densitometry. J Pharm Sci 1978;67(5):639-41.
El Walily AFM, El Gindy A, Bedair MF. Application of first-derivating UV spectrophotometry, TLC-densitometry and liquid chromatography for the simultaneous determination of mebeverine hydrochloride and sulpiride. J Pharm Biomed Anal 1999;21:535-48.
Shama SA, Amin AS. Spectrophotomertric microdetermination of nefopam, mebeverine and phenylpropanolamine hydrochloride in pharmaceutical formulations using alizarins.J Spectrochim Acta A Mol Biomol Spectrosc 2004;60:1969-74.
Zayed SI. Simultaneous determination of mebeverine hydrochloride and sulpiride using the first derivatives of ratio spectra and chemometric methods. J Anal Sci 2005;21:985-9.
El-Didamony AM. Spectrophotometric determination of benzydamine HCl, levamisole HCl andmebeverine HCl through ion-pair complex formation with methyl orange. J Spectrochim Acta A Mol Biomol Spectrosc 2008;69:270-5.
18.Abdelaleem EA, Abdel wahah NS. Validated chromatographic and spectrophotometric methods for analysis of some amoebicide drugs in their combined pharmaceutical preparation. Pak J Pharm Sci 2013:26(1):175-83.
Naouib RA, Abdelkauy M. Development and validation of stability indicating HPLC and HPTLC method for determination of sulpiride and mebeverine hydrochloride in combination. Eur J Med Chem 2010;45(9):3719-25.
20.Patel S, Patel NJ. Spectrophotometric and chromatographic simultaneous estimation of amitriptyline hydrochloride and chlordiazepoxide in tablet dosage form. Indian J Pharm Sci 2009;71(4):472-6.
Patel SK, Patel NJ. Simultaneous RP-HPLC Estimation of Trifluoperazine Hydrochloride and Chlordiazepoxide in Tablet Dosage Forms. Indian J Pharm Sci 2009;71(5):545-7.
Patel S, Patel NJ, Patel SA. Simultaneous Spectrophotometric Estimation of Imipramine Hydrochloride and Chlordiazepoxide in Tablets. Indian J Pharm Sci 2009;71(4):468-72.
Venisetty RK, Kamarapu SK. RP-HPLC Method development and validation for simultaneous estimation of clidinium bromide, chlordiazapoxide and dicyclomine hydrochloride in bulk and combined tablet dosage forms. Int J of Ad Biomed & Pharm Res 2013;2(1):35-40.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use. Validation of Analytical Procedures:Text and Methodology ICH Q2 (R1). 2005.