ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF AMITRIPTYLINE HYDROCHLORIDE AND CHLORDIAZEPOXIDE IN TABLET BY RP-HPLC
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 5
Abstract
A simple, economic, selective, precise, and accurate Reverse Phase High Performance Liquid Chromatography method for analysis of Amitriptyline Hcl & Chlordiazepoxide in tablet dosage form was developed and validated according to ICH guidelines. The quantification of the drug was carried out by using YMC Colimited C8 (250 X 4.6 mm,5μ) column its equivalent in isocratic mode and maintain column at 400C, using mobile phase comprising of Ortho phosphoric Acid : Methanol in the ratio of 50:50 v/v (Adjust pH -2 with Orthophosphoric Acid ), with a flow rate of 1.0mL/min and the detection wavelength was carried at 253 nm. The retention time for Amitriptyline Hcl & Chlordiazepoxide was found to be 2.502&5.176. The percent assay was found to be 101%&99%. Proposed method was validated for precision, accuracy, linearity & range, specificity and robustness according to ICH guidelines. The method was successfully applied to Amitriptyline Hydrochloride and Chlordiazepoxide combination Tablet dosage form.
Authors and Affiliations
Neeli Sujatha K Haritha Pavani
Keywords
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