Development and Validation of Simultaneous Estimation of Canagliflozin and Metformin by Q Absorbance Ratio Method in its API and Tablet Formulation

Abstract

A simple, precise and sensitive UV spectrophotometric method has been developed for the estimation of Canagliflozin and metformin in bulk and pharmaceutical dosage Form by Q Absorbance ratio method. Absorbance uses the ratio of absorbance at two selected wavelengths, one which is an iso absorptive point and other is the λmax of one of the two components. From the overlay spectra of two drugs, it is evident that Canagliflozin and Metformin show an isoabsorptive point at 260nm. The second wavelength used is 235nm which is λmax of Meformin HCl. Beer’s law was obeyed in range of 2-10µg/ml for both Canagliflozin and Metformin HCl. The correlation coefficient was found to be nearer to 0.9990 at both the wavelength for Canagliflozin and Metformin HCl. The result of interday and intraday precision shows standard deviation less than 2% for three concentration and three replicates. The accuracy found to be between 98% - 102%. The LOD and LOQ were found to be within the Linearity Range. The purposed method was novel and can apply for the determination of Canagliflozin and Metformin HCl in Tablet Dosage Form. The method was successfully validated as per the ICH guidelines.