DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF CANAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

A simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on INERTSIL C18 column (150mm×4.6mm,5µm) with a mobile phase combination of Methanol: Acetonitrile: Water (30:50:20 v/v/v) at a flow rate 1.0ml/min and the eluents were monitored at 250nm. Under these LC conditions Canagliflozin peak was eluted at 3.367 min. The developed method was validated as per ICH guidelines. The correlation coefficient values in linearity were found to be 0.999 and concentration range of 20-60µg/ml for canagliflozin and the mean percentage assay was found to be 99.89%. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.                      

Keywords: Canagliflozin, RP‐HPLC, Method development, Validation