DEVELOPMENT OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND CANAGLIFLOZIN AND ITS VALIDATION AS PER ICH GUIDELINES

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Metformin Hydrochloride and Canagliflozin in bulk and dosage forms. The method involves separation on Kromasil C18 column (250mm x 4.6mm x5µm particle size). The optimized mobile phase consists of 0.1% OPA (pH 2.8) and Acetonitrile (45:55v/v) with a flow rate of 1ml/min and UV detection at 254mn. Retention time was 2.112 min (Metformin Hydrochloride), 2.671 min (Canagliflozin). Linearity range was 25-150ug/ml (Metformin Hydrochloride), 2.5-15ug/ml (Canagliflozin). Accuracy was in the range of 98.22-101.54% for both drugs. Precision was 0.63% and 0.65% for Metformin Hydrochloride and Canagliflozin. LOD and LOQ are 0.17ug/ml and 2.20ug/ml for Metformin Hydrochloride, 0.01ug/ml and 0.50ug/ml for Canagliflozin. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 98.55-101.4% of labelled content. Forced degradation studies indicated the suitability of the method for stability studies.