Comparison of UV spectrophotometric and HPLC method for estimating canagliflozin in bulk and a tablet dosage form

Abstract

The aim of the present investigation was to develop, validate and compare a spectrophotometric and a high performance liquid chromatography method for estimating canagliflozin in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 50:50 % v/v of acetonitrile:orthophosphoric acid (0.01 M), which provide a sharp peak with a short retention time of 4.732 minutes. In spectrophotometric analysis, methanol as a solvent gave adequate molar absorptivity at a λ max of 280 nm. Results indicated that both spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of canagliflozin in bulk and a tablet formulations for routine analysis.