HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF GLIBENCLAMIDE IN PHARMACEUTICAL DOSAGE FORMS
Keywords:
Glibenclamide,, Validation,, Hypoglycemic agent, ICH guidelinesAbstract
Glibenclamide is an oral hypoglycemic agent, which increases the insulin secretion by binding to the sulfonylurea receptors on the beta cells or with
ATP sensitive potassium channels on the pancreatic beta cells. The present study includes development of HPLC technique for determination and
estimation of glibenclamide in pharmaceutical dosage forms using acetonitrile: phosphate buffer (70:30) as mobile Phase. The detection wavelength
of glibenclamide was found to be at 235 nm. The developed method was validated for its linearity, precision, accuracy, specificity, robustness and
determination of limit of quantification and limit of detection in the mobile phase. The linearity demonstrated a correlation coefficient of 0.999. Thus,
this method can be considered to be precise, reliable, rapid, simple, sensitive and cost effective for determination of glibenclamide in pharmaceutical
formulations.




