• P-ISSN 0973-7200 E-ISSN 2454-8405
  • Follow us

Journal of Pharmaceutical Research

Article

Validation and Peak Purity Assessment of RP-HPLC Method for Simultaneous Estimation of Amitriptyline HCl, Chlordiazepoxide and Comparison with Spectrophotometry
  • VIEWS 817
  • PDF 576

Journal of Pharmaceutical Research

Year: 2017, Volume: 16, Issue: 3, Pages: 208-217

Original Article

Validation and Peak Purity Assessment of RP-HPLC Method for Simultaneous Estimation of Amitriptyline HCl, Chlordiazepoxide and Comparison with Spectrophotometry

Abstract

Purpose: The study was performed with the aim to design a Simple, precise and economical RP-HPLC method have been developed for simultaneous estimation of amitriptyline HCl and chlordiazepoxide in pharmaceutical formulation.Approach: RP-HPLC was developed using WATERS C18 250 mm � 4.6 mm (5 ?m) column, utilizing a mobile phase of methanol: acetonitrile: 0.2 M orthophosphoric acid, pH 4.5 (adjusted with triethylamine) 56:24:20 ml (with a flow rate of 1ml/min) and U.V detection was carried out at 240nm. Optimization of this method was carried out as a function of mobile phase composition, pH and flow rate. Peak purity was assessed by spectral comparison method.Findings: RP-HPLC method shows linearity in the range of for 0.05-1.6 ?g/ml and 0.01-0.32?g/ml amitriptyline HCl and chlordiazepoxide respectively. The LOD and LOQ values for amitriptyline HCl were 0.0250?g/ml and 0.0759 ?g/ml and 0.0045 ?g/ml and 0.0135 ?g/ml for chlordiazepoxide. The results of % purity was found to be 99.97 � 0.58 % w/w and 99.29 � 0.59 % w/w for HPLC method and 98.87 � 0.03 % w/w and 98.81 � 1.04 % w/w for first derivative spectrophotometric method for amitriptyline HCl and chlordiazepoxide respectively.Conclusion: Results of descriptive statistics studies conclude that RP-HPLC method found to be more sensitive and convenient than first derivative spectrophotometric method.

References

  • Neil MJ O, Patricia H, The Merck Index, 14th Edition, Merck Research Laboratories, USA, 2006.
  • Delgado JN, Remer WA, Wilson and Gisvolds's Textbook of Organic Medicinal and Pharmaceutical Chemistry, 10th Edition, Lippincott-Raven, University of Michigan, Michigan, USA, 1998.
  • Indian Pharmacopoeia, Vol-II, Government of India, The Indian Pharmacopoeia Commission: Ghaziabad, 2007.
  • British Pharmacopoeia, Vol-I, Her Majesty's Stationary Office, London, UK, 2005.
  • The United States Pharmacopoeia, 28th Revision. U.S. Pharmacopoeial convention Inc., Rockville, M.D., USA, 2005.
  • Catherine KM, Eleftheria TM, John EK. Application of two chemometric methods for the determination of imipramine, amitriptyline and perphenazine in content uniformity and drug dissolution studies. Journal of Pharmaceutical & Biomedical Analysis. 2005?37:249�250.
  • French WN, MatsuI FF, Smith SJ. Determination of major impurity in chlordiazepoxide formulations and drug substance. Journal of Pharmaceutical Sciences. 2006; 64:1545�57.
  • Saudagar RB, Saraf S. Spectrophotometric determination of chlordiazepoxide and trifluoperazine hydrochloride from combined dosage form. Indian Journal of Pharmaceutical Sciences. 2007?69:149�152.
  • Toral MI, Richter P, Lara N, Jaque P, Soto C, Saavedra M. Simultaneous determination of chlordiazepoxide and clidinium bromide in pharmaceutical formulations by derivative spectrophotometry. International Journal of Pharmaceutics. 1999? 189:67�74.
  • Karpinska J, Suszynska J, Trace J. The spectrophotometric simultaneous determination of amitriptyline and chloropromazine hydrochlorides in their binary mixtures. Microprobe. Tech., 2001; 19(3): 355-364.
  • Patel S, Patel NJ. Spectrophotometric and chromatographic simultaneous estimation of amitriptyline hydrochloride and chlordiazepoxide in tablet dosage forms. Indian Journal of Pharmaceutical Sciences. 2009; 71(4): 472�476.
  • Sujatha N, Pavani KH. Analytical method development and validation of amitriptyline hydrochloride and chlordiazepoxide in tablet by RP-HPLC. Indian Journal of Research in Pharmacy and Biotechnology. 2013; 1 (5): 655�659.
  • Raju R, Dammalapati S. Method development and validation of chlordiazepoxide and amitryptyline hydrochloride in pharmaceutical formulations by RP-HPLC. Asian Journal of Biomedical & Pharmaceutical Sciences. 2014; 4(32): 32�38.
  • Rania N, Shaheny EI, Belal F. Simultaneous HPLC determination of chlordiazepoxide and mebeverine HCl in the presence of their degradation products and impurities. Journal of Chemistry. 2015; 2015: 9.
  • Validation of analytical procedures. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Q2A-B, Geneva, 2005.

DON'T MISS OUT!

Subscribe now for latest articles and news.