Abstract

A NEW RP-HPLC METHOD DEVELOPMENT FOR SIMULTANEOUS ESTIMATION OF METFORMIN AND ALOGLIPTIN IN BULK AS WELL AS IN PHARMACEUTICAL FORMULATION BY USING PDA DETECTOR

G. Satya Sri*, S. Ashutosh Kumar, J. Saravanan, Manidipa Debnath, V. Greeshma,
N. Sai Krishna

ABSTRACT

Metformin is a biguanide antihyperglycemic agent used for treating non-insulin- dependent diabetes mellitus (NIDDM). It improves glycemic control by decreasing hepatic glucose production, decreasing glucose absorption and increasing insulin-mediated glucose uptake. Metformin is the only oral antihyperglycemic agent that is not associated with weight gain. Alogliptin is a selective, orallybioavailable inhibitor of enzymatic activity of dipeptidyl peptidase-4. A new reversed-phase High Pressure Liquid Chromatographic (RPHPLC) method was developed for the determination of Metformin & Alogliptin (ALG) based on isocratic elution using a mobile phase consisting of potassium dihydrogen phosphate buffer [pH 4.0] and Acetonitrile [HPLC Grade] (70:30, v/v) at a flow rate of 1 mL min−1with UV detection at 235nm. The chromatographic separation was achieved on a XTerra column (250 mm × 4.6 mm, 5 μm). The run time was maintained for 8mins. The Inter day and intraday precision was found to be within the limits. The Accuracy values were within specified limits (98-102%) The calibration curve for Metformin was linear from (300-700 μg mL) and for Alogliptin from (7.5-17.5 μg /ml).The Limit of Detection for Metformin and Alogliptin was found to be 0.175 and 0.050 μg/ml respectively. The Limit of Quantification for Metformin and Alogliptin was found to be 0.57and 0.20 μg/ml respectively. The proposed method was adequate sensitive, reproducible, and specific for the determination of Metformin and Alogliptin bulk as well as in its tablet dosage forms. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. Overall the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in Pharmaceutical dosage form.

Keywords: Metformin, Alogliptin, ICH Guideline, Validation, LOD, LOQ, Accuracy, Precision.