Development and validation of stability-indicating UPLC method for the determination of gliclazide and its impurities in pharmaceutical dosage forms

Abstract

A stability indicating method was developed for the estimation of Reserpine in pharmaceutical dosage form by using Ultra performance Liquid chromatography (UPLC). The separation was done on gradient mode with Hibra C18 (100mm × 2.1mm, 5 μ) column and mobile phase consisting of Acetonitrile and buffer 70:30 (v/v) were used and flow rate was maintained at 1ml/min at room temperature. The detection was done at a wave length of 240nm. A good linearity was observed with a correlation coefficient of 0.999. The method was validated according to the ICH guidelines. The developed method was found to be accurate and precise, with %recovery 99.95-100.18% and % relative standard deviation. The drug was found to be stable at forced degradation conditions and the net degradation was found to be within the limits. The developed method can be used for the quality control of Reserpine in pharmaceutical dosage form.