Abstract

METHOD DEVLOPMENT AND VALIDATION OF METFORMN AND GLIMEPIRIDE IN TABLET DOSAGE FORM BY RP-HPLC METHOD

Somnath Gaikwad*, Dr.Laxman Kavale, Namrata Bhirud, Rahinj Bebi,Nitin Girawale, Mayur Gandhi

Abstract

The present work was undertaken with an objective to develop an accurate, simple, precise and reliable method for estimation of Metformin and Glimepiride in their combined dosage form. An RPHPLC method was developed and validated for the determination of Metformin and Glimepiride in tablet dosage form. The analytes were resolved by using gradient programme. Hypersil Gold C18 column (4.6 x 250 mm, 5 μ) is used for separation and injection volume was 20 μL, mobile phase used is Methanol: Phosphate buffer (pH-3), at a flow rate of 0.8ml/min, on HPLC auto-sampler system containing UVvisible detector with Workstation Software. The detection of Metformin and Glimepiride were carried out at 237 nm and 228 nm respectively and isobestic point at 241 nm. The method gave the good resolution and suitable retention time. The results of analysis in all the method were validated as per ICH guidelines.

Keywords: Metformin, Glimepiride, RP-HPLC, Validation, Gradient system.