Abstract

STABILITY INDICATING ASSAY METHOD BY HPLC FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND GLIPIZIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sabyasachi Mandal*, Bhumi Patel, Dr. Anirbandeep Bose, Dr. Gurubasavaraja Swamy, Shree Narayan Pandit, Dr. Divakar Goli

ABSTRACT

A simple, rapid, precise and accurate isocratic reversed-phase stability indicating HPLC method was developed and validated for simultaneous estimation of Metformin and Glipizide in bulk drug and pharmaceutical dosage form using Phenomenex Luna C18 column (250 mm × 4.6 mm id, 5 μm) and a mobile phase of Acetonitrile: Water, 0.2% triethylamine (pH 3.0 adjusted with ortho-phosphoric acid) (60:40 v/v), at flow rate 0.8 ml/min with UV detection at 258 nm. The retention time (tR) of Metformin and Glipizide were found to be 2.4 and 5.3 min, respectively. The drugs were subjected to oxidation, hydrolysis, photolysis, and heat to apply stress conditions. Linearity for Metformin was in the range of 100-500 μg/ml and Glipizide was in the range of 1-5 μg/ml. Their regression co-efficient (r2) were found to be 0.9984 and 0.9987 for Metformin and Glipizide respectively. The percentage recovery for Metformin and Glipizide was found to be 99.54 ± 0.73 - 101.50 ± 1.69 and 100.44 ± 0.13 - 101.5 ± 0.81, respectively. LOD of proposed method was found to be 4.19μg/ml for Metformin and 0.113μg/ml for Glipizide respectively whereas LOQ was found to be 12.6μg/ml for Metformin and 0.34μg/ml for Glipizide. The method was validated statistically and results were compared with ICH parameters. Degradation products produced as a result of stress studies did not interfere with the detection of Metformin and Glipizide and the assay can thus be considered stability indicating.

Keywords: RP-HPLC Method, Metformin, Glipizide, Stability-indicating.