Development and Validation of RP-HPLC Method for Estimation of Gliclazide in Bulk and Tablet Dosage Form

摘要

ABSTRACT A simple, selective and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Gliclazide in bulk and in tablet dosage form has been developed and validated. Sample was analysed on a Enable C18 (250mm X 4.6 mm i.d, particle size 5μm) column. The mobile phase consist of Methanol: Water (pH 3.5) in the ratio of 85:15v/v which was sonicated to degased and delivered at a flow rate of 1ml/min at ambient temperature. The retention time of Gliclazidewas 3.7+0.02 minutes. Studies were performed using an HPLC system equipped with a UV detector; the response was monitored at 230 nm.The calibration curve was linear over the concentration range of 20-70 μg/ml (r2=0.999). The limit of detection for Gliclazide was found to be 0.2438 μg/ml and the limit of quantification limit was about 0.7388 μg/ml. The accuracy of the method was established based on the recovery studies. The proposed method can be applied to the routine analysis of Gliclazide in bulk and in tablet dosage form. Keywords: Gliclazide, ICH, RP-HPLC, Validation.