ABSTRACT:
Objective: 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. Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating beta cells of the pancreas to release insulin. Method: This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method for the determination of Metformin [MFH] and Gliclazide [GZ] combination drug in its tablet dosage forms. Result: The HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 x 150mm, 5 micrometer) with a mobile phase composed mixture of 0.1% Orthophosporic Acid and Acetonitrile in the ratio of 35:65 v/v in isocratic mode at a flow rate of 0.8 ml/min. The run time was maintained 6mins. The detection was monitored at 230 nm. The retention time was 1.7min for [MFH] and 3.2min for [GZ]. The Accuracy was calculated and the % Recovery was found 98.0%-102.0% and reproducibility was found to be satisfactory .The calibration curve was linear over the concentration range of 20-60 µg/ml for [MFH] and 3.2-9.6µg/ml for [GZ] was found to be within limits. Conclusion: The proposed method was adequate sensitivity, reproducibility, and specificity for the determination of [MFH] and [GZ] in its tablet dosage forms. The limit of detection and limit of quantification for [MFH] and [GZ] were found to be 0.018 µg/ml, 0.03 µg /ml and 0.005 µg /ml, 0.11µg /ml respectively. 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 a short period of time as per ICH guideline. The proposed method is simple, fast, accurate, and precise for the quantification of [MFH] and [GZ] in the dosage form.