DEVELOPMENT AND VALIDATION OF A LIQUID CHROMATOGRAPHIC METHOD FOR ESTIMATION OF GLIMEPIRIDE IN TABLET DOSAGE FORMAbstract
An accurate, sensitive and precise RP-HPLC method has been developed and validated for the estimation of Glimepiride (GLM) from bulk drug and Pharmaceutical Dosage form. The separation was achieved by Hypersil C18 column (250mm X 4.6mm, 5μm) in isocratic mode, with mobile phase comprises of Acetonitrile : Buffer in proportion of 60:40v/v, buffer was 0.02M Potassium Di-hydrogen Phosphate (pH 4.5 adjusted with Ortho Phosphoric Acid). The flow rate of mobile phase was 1.0ml/min and employing UV detection with 232nm wavelengths. The retention time of GLM was 5.420 min.The calibration curve was found to be linear within the concentration range of 50µg/ml to 150µg/ml. The regression data for calibration curve shows good linear relationship with r2 = 0.9965. The method was validated in accordance with the requirements of ICH guidelines. Moreover, the proposed analytical method was applied to monitor the formulation commercially available.
Vaishali V. Karkhanis* and Anandkumari D. Captain
A.R. College of Pharmacy , Vallabh Vidhyanagar - 388120, Dist: Anand, Gujarat, India
12 March, 2013
30 April, 2013
25 June, 2013
01 July, 2013