Development and Validation of Stability-Indicating RP-Hplc Method for Simultaneous Determination of Canagliflozin and Metformin in Fixed-Dose Combination

A new HPLC method has been developed and validated with different parameters for the estimation of Canagliflozin and Metformin in Fixed-Dose Combination. The chromatograms were developed using a mobile phase of Methanol: 0.1 % OPA in water (35:65) with a flow rate of 0.7 ml/min. C18 Column of 4.6 x 100 mm dimension was used as a stationary phase, particle size 5um. The detection was carried out at 245 nm. The method was validated according to ICH guidelines for linearity, precision and Repeatability, Robustness, LOD, and LOQ. The response was found to be linear in a concentration range of 100-500 mu g/ml for Metformin and 10-50 mu g/mL for Canagliflozin. The stability studies of Metformin and Canagliflozin were also done through the exposure of analyte solution to different stress conditions. The developed HPLC method of Metformin and Canagliflozin was simple, precise, accurate, reproducible, and therefore suitable for routine analysis of drugs in a dosage form.