Development and Validation of Reverse Phase High Performance Liquid Chromatography Method for the Estimation of Canagliflozin in Bulk and its Pharmaceutical Formulation

Objectives: Study was initiated to develop simple, specific, precise, selective and accurate reverse phase high performance liquid chromatographic method for the estimation of canagliflozin in bulk and pharmaceutical formulation. Sodium glucose co-transporter 2 inhibitors for glycemic control activity are categorized under type 2 classification under antidiabetic drugs. Methods: Development of method was initiated by determining solubility in acetonitrile and detection at 290nm for the drug canagliflozin. The chromatographic separation was achieved on Shimadzu LC-20AT (Shimadzu Corporation, Japan). The system for chromatographic analysis was equipped with binary low-pressure mixing pump (LC-20AT) and an UV-detector (Shimadzu SPD-20A), a Princeton C18 column (250 x 4.6mm; 5µm), 20 µl sample loop volume. Results: Concurrent results were obtained in the developed and optimized method. Linearity was found to be 0.998 over the range of 0.098µg/ml– 50µg/ml. Sensitivity of the developed method was 98ng/ml. The mobile phase optimized for method was composed of acetonitrile: water (50:50, %v/v) at a flow rate of 1.0 ml/min. Canagliflozin was detected at 290 nm with retention time of 7.3±0.2 min in concurrent manner. Quantitative assay of the marketed formulation had been carried out and the percentage of drug was determined in the limits of specification. Percentage recovery was found between 98.9 to 99.8%, Accuracy and precision studies performed had achieved metrics under the specified limits. The validation was successfully performed according to ICH guideline Q2R1. Conclusion: The developed method can be employed for the estimation of canagliflozin in pharmaceutical formulation and also for a bioequivalence study to evaluate its applicability further.