METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF GLYBURIDE (GLIBENCLAMIDE) IN PHARMACEUTICAL FORMULATIONS AND RAT PLASMA BY RP-HPLC
Author(s):
Mallikarjun Bere, Pasham Venkanna
Keywords:
Glyburide, RP-HPLC, Validation and method development
Abstract
A simple, reproducible and efficient reverse phase high performance liquid chromatographic method was developed for determination of glyburide in pure form and marketed pharmaceutical dosage forms. A column having Kromasil ODS 3V (250×4.6mm, 5µ) in isocratic mode with mobile phase containing acetonitrile (ACN): phosphate buffer (60:40v/v) was used. The flow rate was 1.0 ml/min and effluent was monitored at 238 nm. The method has been validated for linearity, accuracy and precision, robustness and limit of detection and limit of quantitation. The retention time (min) and linearity range for glyburide was (2.262 min) and (10-50 µg/ml), respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.02µg/ml and 0.05µg/ml for glyburide. The developed method was found to be accurate, precise and selective for determination of glyburide in pharmaceutical dosage forms. The short retention time allows the analysis of a large number of samples in a short period of time and, therefore, should be cost effective for routine quality control in the pharmaceutical industry.
Article Details
Unique Paper ID: 152576

Publication Volume & Issue: Volume 8, Issue 3

Page(s): 833 - 844
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