Abstract
Author(s): Bhushan Vijay Surve, Ram Lokhande, Ravi Yadav
A simple, specific, linear, sensitive, precise, efficient Reverse phase HPLC method was developed and validated for the Assay determination of Glyburide Active Pharmaceutical ingredient (API.) The proposed method involves use of Ascentis Express C18; 7.5cm x 4.6mm, 2.7µcolumn and mobile phase comprising of mixture of 0.1%Triethyl amine with pH adjusted to 3 with Ortho phosphoric acid and Acetonitrile (45:55) v/v. The column temperature is maintained at 50ºC and flow rate at 1 ml/minute. Detector used is a UV (Ultra violet- Visible) detectorat wavelength of 254 nm. The retention time of active ingredient is about 2 minutes.The method was validated for specificity, system suitability, linearity, precision androbustness. Method is specific as no interference was observed at Retention time of Principle peak due to Glyburide. The linear regression analysis data for the calibration plots showed a linear relationship over the concentration range of 26.13-78.38 ppm for active ingredient. Percentage RSD of active ingredient was found to below 2%. Statistical analysis showed that the method is repeatable and selective for the Assay determination of GluburideActive Pharmaceutical ingredient (API.)
