Method Development and Validation of Metformin and Gliclazide in Tablet dosage form by Micellar Liquid Chromatography

Abstract

Micellar Liquid Chromatography (MLC) has emerged as a promising technique for the analysis of Pharmaceutical compounds due to its versatility, efficiency, and cost-effectiveness. In this experimental research paper, we explore the application of MLC in the simultaneous analysis of two commonly prescribed antidiabetic drugs, Metformin and gliclazide. A combination of these medicines is widely used to treat type 2 diabetes mellitus, so accurate quantification of them is essential for efficient therapeutic management. To separate the drug formulation, reversed phase liquid chromatography (RP-HPLC) was employed using surfactant solutions above Critical Miceller concentration (CMC). The mobile phase included 0.10M SDS and 10% Propanol-1, with a pH of 3.50 maintained by o-Phosphoric Acid and analysis was done using Deoxyprobe C18 column (4.6 x 150 mm, 5 µm). The separation was carried out at room temperature with a flow rate of 1.0 ml/min, and detection was performed at 228 nm. Gliclazide has a retention time of 4.46 minutes, compared to 5.57 minutes for metformin. The percentage composition of the sample under analysis ranged from 90 to 110 percent in accordance with schedule V of the Drug and Cosmetic Act. The suggested practice met ICH requirements. The method was also low-cost, easy to use, secure, and ecologically benign. It can be used to conduct standard quantitative analyses on pills that include metformin and gliclazide.