Stability Indicating Assay Method Development and Validation to Simultaneously Estimate Metformin Hydrochloride and Canagliflozin by RP-HPLC

Order of Publishing in Issue: 
5
Volume :10
Issue :4
October, 2016
Page No: 
334-342
Authors: 
Sonia D’souza, Muddu Krishna, Gude Sai Sushmitha and S. G. Vasantharaju*
Address: 
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, India

Abstract

The focus of this study is to develop and validate a HPLC method to simultaneously estimatemetformin hydrochloride and canagliflozin in bulk using GraceSmart RP-18 column (250× 4.6mm, 5μ)at 30°C.Combination of acetonitrile(ACN) and ammonium acetate bufferin the ratio of 45:55v/v with pH 4.5 was used as mobile phase with 1ml/min flow rate. It was detected by photo diode array detector at 252 nm. The retention timeobserved for metformin hydrochloride and canagliflozin were found to be 4.00 and 5.76 min respectively. The method was developed and found to be linear with correlation coefficients r2 of 0.9993 and 0.9992 for metformin hydrochloride and canagliflozin respectively within a concentration range of 1- 80μg/ml. Stability studies were performed by exposing the drugs to acidic, basic, oxidative, thermal and photolytic stress conditions with sampleswithdrawn at different time intervals. Analysis of the above samples were done by the developed method. The method to estimate metformin hydrochloride and canagliflozin in bulk drug is easy, accurate, precise and less time consuming.

Keywords: Metformin hydrochloride, Canagliflozin, RP-HPLC, Validation, Stability indicating.

Keywords: 
Metformin hydrochloride, Canagliflozin, RP-HPLC, Validation, Stability indicating.
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