Abstract

METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE AND GLICLAZIDE FOR RP-HPLC METHOD DEVELOPMENT, VALIDATION IN PURE DRUG FORM AND IN A SYNTHETIC MIXTURE

Amareshwar Shabada, *Syeda Saba Sultana, Humera Badar and Nikhat Fatima

ABSTRACT

A new, simple, accurate, precise and selective reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide as API and in synthetic mixture is developed. The determination was carried out on a ODS, (250 X 4.6 mm, 5 μm) column using a mobile phase of buffer solution: acetonitrile (55:45% v/v, pH 5.0). The flow rate was 1.0 ml/min with detection at 230 nm. The retention time for Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide were 2.11 min, 8.6 min and 10.49 min respectively. Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazidel showed a linear response in the concentration range of 50-350μg/ml, 1.5- 10.5μg/ml and 6-42μg/ml respectively. The results of analysis have been validated statistically and by recovery studies. The mean recoveries found for Metformin hydrochloride was 99.05%, Pioglitazone hydrochloride was 99.91% and Gliclazide was 99.26%. Developed method was found to be simple, accurate, precise and selective for simultaneous estimation of Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide as API and in synthetic mixture.

Keywords: Simultaneous estimation, RP-HPLC method, Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide.