Development and Validation of HPLC Method for Simultaneous Determination of Gliclazide and Enalapril Maleate in Tablet Dosage Form

Abstract

This paper describes a simple, sensitive and selective high performance liquid chromatographic
(HPLC) method for the separation and determination of gliclazide (GLI) and enalapril (ENA) maleate simultaneously
in tablet dosage forms. The chromatographic separation was performed on an ODS column (250 mm × 4.6 mm i.d., 5
μm particle size) at 40 ± 0.5°C, with a mobile phase composed of phosphate buffer (pH 4.4), acetonitrile and
methanol in the ratio of 45:40:15, (v/v/v). The flow rate was maintained at 1.5 ml/min, injected volume was 20 μl and
detection wavelength was 217 nm. The method was validated according to ICH Q2 (R1) guidelines and found to be
linear over a range of 40-120 μg/ml (R2 = 0.991) and 2.5-7.5 μg/ml (R2 = 0.998) for gliclazide and enalapril maleate,
respectively. The proposed method was applied successfully for the assay of these two drugs in their combined inhouse
developed tablet formulations and could be applicable for routine quality control analysis.