Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN, GLIMEPIRIDE AND ATORVASTATIN IN COMBINED TABLET DOSAGE FORM BY UPLC

Meghana Reddy.Regalla* , Thaduvai.Venkata Ravindranath

ABSTRACT

An accurate, precise , reproducible and eco friendly Reverse Phase Ultra Performance Liquid chromatography (RP-UPLC) method was developed and validated for the estimation of Metformin Hydrochloride, Glimepiride and Atorvastatin in Pharmaceutical dosage forms. In this method BEH C18 (1.7 x 100mm, 2.1m) column with mobile phase containing phosphate buffer(pH adjusted to 3 with orthophosphoric acid) and acetonitrile in the ratio of 40:60v/v was used. The flow rate was 0.4ml/min. and the detection wavelength was 243nm. The linearity was observed in the range of 40 - 120μg/ml, 0.8 - 2.4 μg/ml and 0.16 – 0.48 μg/ml for Metformin Hydrochloride, Glimepiride and Atorvastatin with correlation coefficient of 0.9992, 0.9992, and 0.9997 respectively. Retention times were 0.551, 1.541 and 1.924 min for Metformin Hydrochloride, Atorvastatin and Glimepiride respectively. The proposed method was validated for linearity, accuracy, precision and robustness. The proposed method was validated as per ICH guidelines and can be applied for routine quality control analysis of pharmaceutical dosage forms used for multidrug therapy containing Metformin Hydrochloride, Glimepiride and Atorvastatin.

Keywords: UPLC, OPA, multidrug therapy, ICH, Validation, STATOR GM2.