Development and Validation of New RP-HPLC Method for the Estimation of Antidiabetic Drugs Metformin Hydrochloride and Gemigliptin in Combined Pharmaceutical Dosage Form

Abstract

Metformin Hydrochloride and Gemigliptin is combination of Antidiabetic drug in tablet Zemimet SR ® Tablet (25/500 mg), a member Antidiabetic drug, is a recent drug developed by LG Life sciences for the treatment of Type 2 diabetes. A new sensitive and rapid HPLC method was developed for the determination of Metformin Hydrochloride and Gemigliptin in pharmaceutical dosage forms; it was validated according to International Conference on Harmonization and Food and Drug Administration guidelines. The analysis was performed on the HPLC system equipped with a using Gemni C18, (5 µm) (250 mm x 4.6 mm), with of Buffer (20mM Ammonium Acetate in water, pH 3.5) and Methanol: Acetonitrile 40:10 (%V/V) 60: 40 v/v with at a flow rate of 1.0 mL/min, column temperature 35°C, total run time was 10 min, injection volume 10 μl, and detection was performed at the wavelength (λ) of 265 nm. The calibration plot gave linear relationship over the concentration range of Metformin Hydrochloride 20, 40, 100, 200, 400 and 500 μg/ml, and Gemigliptin 1, 2, 5, 10, 20 and 25 μg/ml, respectively. The accuracy of the proposed method was determined by recovery studies and was found to be Metformin Hydrochloride 99.0 % to 101.0 % and Gemigliptin 98.0 % to 100.0 %.The Limit of Detection were 50.56 and 14.21 μg/ml for Metformin Hydrochloride and Gemigliptin, respectively and the Limit of Quantitation were 166.85 and 43.90 μg/ml for Metformin Hydrochloride and Gemigliptin, respectively% Relative Standard Deviation of the determination of precision was <2%. The results of robustness and solutions stability studies were within the acceptable limits as well the main features of the developed method are low run time and retention time of around 2.9 min for Metformin Hydrochloride (Met) and 7.4 min for Gemigliptin.