Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin, Pioglitazone and Gliclazide from Bulk and Tablet Dosage Form

Author(s)

Patel, T. A., Patel, M. M., Patel, C. N.

Author's Affiliation

Abstract

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous estimation of Metformin Hydrochloride, Pioglitazone hydrochloride and Gliclazide in pure and tablet formulation. Chromatography was performed on a WATER C18 (250mm×4.6 mm, 5.0 μm) analytical column with phosphate buffer (pH adjusted to 4.2 using o-phosphoric acid): Acetonitrile in the ratio of 45:55 (v/v) as mobile phase at a flow rate of 1.0 ml/min and effluents was monitored at 228 nm. Metformin hydrochloride, Pioglitazone hydrochloride and Gliclazide were eluted with retention times of 2.515 min, 5.178 min and 6.903 min respectively. The method was statistically validated as per ICH guideline for analytical method validation.

Keywords

Metformin hydrochloride, Pioglitazone hydrochloride, Gliclazide, Tablet Formulation, Validation

Cite This Article

Patel, T. A., Patel, M. M., & Patel, C. N. (2014). Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin, Pioglitazone and Gliclazide from Bulk and Tablet Dosage Form. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(4), 115-121.