Development and Validation of a Stability-Indicating Reverse Phase HPLC-PDA Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form

Abstract

Objective: To develop and validate simple, authentic and stability indicating high performance liquid chromatographic method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Q2 R1 Guidelines. Methods: A C 18 Column (250×4.6 mm, 5 μm particle size) with a mobile phase consisting of Acetonitrile: orthophosphoric acid in a ratio of 55:45 v/v was employed for the chromatographic study. A flow rate of 1 ml/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Results: The separation was achieved at a temperature of 30oC and the eluents were observed by photo diode array detector set at 290 nm. A linear range of 1-6 μg/ ml with a correlation coefficient of 0.998 unfolds good linear relationship between area and concentration in calibration curve. The retention time obtained was at 6.29 min. The LOD and LOQ were found to be 0.41 μg/ml and 1.24 μg/ml respectively. A recovery of Canagliflozin in tablet formulation was observed in the range of 99.6-99.8%. Percentage assay of Canagliflozin tablets (INVOKANA®) was found to be 99.92%. The stability of the method was demonstrated by forced degradation studies of drug in which it was degraded under conditions of hydrolysis (acidic and alkaline), oxidation, photolytic and thermal stress as per ICH guideline Q1A (R2). Conclusion: The proposed method is definite, meticulous and reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form. Key words: Canagliflozin, High Performance Liquid Chromatography, Method development, Stability, Validation.