HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF GLIBENCLAMIDE IN PHARMACEUTICAL DOSAGE FORMS

Authors

  • Ashwini M
  • Sogali B S
  • Bhattacharyya S

Keywords:

ICH guidelines, Hypoglycemic agent,, Validation, Glibenclamide

Abstract

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.

 

 

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Published

02-03-2019