Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE (PIO), METFORMIN HYDROCHLORIDE (MET) AND GLIMEPIRIDE (GLI) IN THE PHARMACEUTICAL DOSAGE FORM

Rizwanali Saiyed*, Yash Patel, Bhaumik Machhi, Yami Patel, Ami Bhoi, Prof. Mitali Dalwadi, Dr. Chainesh Shah and Dr. Umesh Upadhyay

ABSTRACT

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Pioglitazone (PIO), Metformin Hydrochloride (MET), And Glimepiride (GLI) present in tablet dosage forms. Chromatography is carried out isocratically at 25°C ± 0.5°C on an Inertsil-ODS-3 (C-18) Column (250 × 4.60 mm, 5 μm) with a mobile phase composed of acetonitrile, methanol and phosphate buffer (15:50:35 v/v, pH 3 adjusted with ortho phosphoric acid) at a flow rate of 1 mL/min with UV detection b/w 200-400 nm. The retention times of Pioglitazone (PIO), Metformin Hydrochloride (MET), And Glimepiride (GLI) were found to be 9.39 min, 2.57 min, and 7.06 min, respectively. Linearity was established for Pioglitazone (PIO), Metformin Hydrochloride (MET), and Glimepiride (GLI) in the range of 1-40 μg/ml, 50-200 μg/ml and 0.5-40 μg/ml, respectively. The recovery was in the range of 98.75-102.10% for Pioglitazone (PIO), 98.61-101.91% for Metformin Hydrochloride (MET) and 97.50-103.33% for Glimepiride (GLI) respectively. Both the drugs were subjected to variance of conditions like flow, difference in mobile phase and concluded that this method are often successfully employed for simultaneous quantitative chemical analysis of PIO, MET and GLI in bulk drugs and formulations.

Keywords: Pioglitazone (PIO), Metformin Hydrochloride (MET), And Glimepiride (GLI) RP-HPLC, Bulk drugs, Pharmaceutical formulations.