Abstract

DEVELOPMENT AND VALIDATION OF A REVERSED-PHASE HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN AND GLICLAZIDE IN TABLET DOSAGE FORMS

Gandla. Kumara Swamy*, N. Ravindra, Ch.Anjali

ABSTRACT

A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Metformin and Gliclazide in tablets. The chromatographic separation was carried out on an Cosmosil ODS analytical column (250×4.6 mm; 5μm) with a mixture of Methanol: Hplc grade water pH 6 adjusted with Orthophosphoric acid(70:30, v/v) as mobile phase; at a flow rate of 1 ml/min. UV detection was performed at 235 nm. The retention times were 2.50 and 6.02 min. for Metformin and Gliclazide, respectively. Calibration plots were linear (r2>0.998) over the concentration range 5-30μg/ml for Metformin and 1-6μg/ml Gliclazide. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Metformin and Gliclazide in bulk drug and tablets dosage form.

Keywords: Metformin, Gliclazide, RP-HPLC Method;Tablet Dosage forms.