Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANIOUS DETERMINATION OF METFORMIN AND CANAGLIFLOZIN IN PHARMACEUTICAL FORMULATION

Deepak Gaware*, R. N. Patil and Mangesh Harole

ABSTRACT

The proposed study, a new stability indicating RP-HPLC method has been developed for estimation of metformin and canagliflozin in bulk and pharmaceutical dosage form. The present method was a sensitive, precise and RP-HPLC method for analysis of metformin and canagliflozin. To optimize the mobile phase various combinations of organic solvents were used on Kromosil C18 250 column, Then the mobile phase containing a mixture of phosphate buffer and acetonitrile in the ratio of 65:35% v/v was selected at a flow rate of 1.0ml/min for developing the method and the peak with a good shape and resolution were found resulting in short retention time baseline stability and minimum noise. The retention time metformin and canagliflozin found to be 2.413 and 3.548 min respectively, quantitative linearity was obeyed in the concentration range of 50-300μg/ml and 5-30 μg/ml of metformin and canagliflozin respectively. The limit of detection and limit of quantitation were found to be 0.30μg/ml and 0.91μg/ml (metformin), 0.361μg/ml and 1.094μg/ml (canagliflozin) respectively, which indicates the sensitivity of the method. The high percentage recovery indicates that the proposed method is highly accurate no interfering peaks were found in the chromatogram indicating that excipients used in tablet formulation didn’t interfere with the estimation of the drug by the proposed HPLC method.

Keywords: RP-HPLC, Method development, metformin, canagliflozin.