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

摘要

Objective: To develop and validate simple, authentic and stability indicatinghigh performance liquid chromatographic method for determination ofCanagliflozin in bulk and pharmaceutical formulations as per ICH Q2 R1Guidelines. Methods: A C18 Column (250×4.6 mm, 5 μm particle size) witha mobile phase consisting of Acetonitrile: orthophosphoric acid in a ratioof 55:45 v/v was employed for the chromatographic study. A flow rate of1 ml/min with an injection volume of 20 μL was selected for this studyand the proposed method was validated with different parameters suchas Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection(LOD) and Limit of Quantification (LOQ). Results: The separationwas achieved at a temperature of 30oC and the eluents were observedby 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 relationshipbetween area and concentration in calibration curve. The retentiontime obtained was at 6.29 min. The LOD and LOQ were found to be0.41 μg/ml and 1.24 μg/ml respectively. A recovery of Canagliflozin in tabletformulation was observed in the range of 99.6-99.8%. Percentage assay ofCanagliflozin tablets (INVOKANA?) was found to be 99.92%. The stabilityof the method was demonstrated by forced degradation studies of drug inwhich 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 reproducibleand can be used for routine analysis of Canagliflozin in bulk and pharmaceuticaldosage form.