Development and Validation of a Stability-Indicating RP-HPLC Method for Estimation of Glibenclamidei Bulk and Pharmaceutical Formulation

Abstract

Glibenclamide is the choice of medicine for diabetes type II. There are numerous methods for estimation; however the methods are either not suitable or expensive. A simple, cheap, precise, and accurate stability-indicating HPLC method was developed and further validated. The wavelength of 229 nm with a constant flow rate of (Methanol: Mixed Phosphate Buffer, 70:30% v/v (pH 7.3)) 1 mL/min was used during the experimentation. The run time was (run time). The internal standard used was (Internal standard). The sample eluted and showed a sharp peak at 2.1 minutes. It was discovered that calibration curve experiments had a 5–50 ppm linearity. The precision of the developed method was lower than 2% RSD. Recovery studies showed that the method’s accuracy and precision ranged from 99.25 to 101.81%. Stress testing was used to determine specificity. The developed method was capable of separating the drug peak from any probable degradation products. There was no evidence of recipient or impurity interference. The method can be used to anticipate how long glibenclamide will be stable. The method was feasible and appropriate for analyzing the presence of glibenclamide in a drug substance as well as a drug product.