Simultaneous Estimation and Validation of Canagliflozin and Metformin Hydrochloride in Bulk and Pharmaceutical Dosage Form by using RP-HPLC

Abstract

The first reversed phase high performance liquid chromatographic method for simultaneous determination of, Canagliflozin and Metformin has been developed and validated to be a simple, sensitive, rapid, specific, precise, and accurate method. Chromatographic separation was achieved on C18 column (250×4.6 mm-5μm p.s). Methanol and potassium dihydrogen phosphate buffer in a ratio [90:10 v/v] as a mobile phase at flow rate of 0.9ml/min. UV detection was operated at 222 nm and injection volume was 20 μl. The proposed method showed good linearity, accuracy, precision and was successfully applied for determination of the drugs in laboratory prepared pharmaceutical dosage forms. The current method has been statistically validated according to the ICH guidelines and this method has been subsequently developed and applied successfully to determine the levels of Metformin hydrochloride and Canagliflozin in a combined formulation and in the routine quality control analysis with good accuracy and sensitivity.