Abstract

DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND CANAGLIFLOZIN AND ITS COMPARISON WITH THE REPORTED METHODS

Vinutha Kommineni, K.P.R. Chowdary* and S.V.U.M. Prasad

ABSTRACT

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 254nm. Retention time was 2.112 min for Metformin Hydrochloride, 2.671 min for Canagliflozin. RPHPLC method for the simultaneous estimation of Metformin Hydrochloride and Canagliflozin in their combine dosage form was developed and validated as per the ICH guidelines. Linearity was observed in the range of 25150μg/ ml for Metformin Hydrochloride and 2.515μg/ ml for Canagliflozin with correlation coefficients (r2=0.999). The percentage recoveries of Metformin Hydrochloride and Canagliflozin were in the range of 98.2101.4% which was with in the acceptance criteria. The percentage RSD was NMT 2% which proved the precision of the developed method. When applied for tablet assay, drug content was within 98.55-101.4% of labeled content. Forced degradation studies indicated the suitability of the method for stability studies. When the validation parameters of the method developed are compared with those of the earlier reported methods the developed method was found superior in certain respects such as RT, LOD and the method was more economical when compared to others. Accuracy and precision, ruggedness and robustness were similar to earlier reported methods.

Keywords: Metformin Hydrochloride, Canagliflozin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.