Rapid Analysis of Glibenclamide Using an Environmentally Benign Stability-Indicating RP-HPLC Method.

Abstract

An environmentally benign RP-HPLC approach for rapid analysis of glibenclamide in pure form, developed nanoemulsion and commercial tablets was developed and validated in present investigation. The green chromatographic identification was performed on Lichrosphere 250 X 4.0 mm RP C8 column having a 5 μm packing as a stationary phase using a combination of ethanol: methanol (50:50 % v/v) as a mobile phase, at a flow rate of 1.0 mL/min with UV detection at 245 nm. The proposed method was validated for linearity, selectivity, accuracy, precision, robustness, sensitivity and specificity as per international conference on harmonization (ICH) guidelines. The utility of proposed method was verified by assay of glibenclamide in developed nanoemulsion and commercial tablets. The proposed method was found to be satisfactory in terms of selectivity, precision, accuracy, robustness, sensitivity and specificity. The content of glibenclamide in developed nanoemulsion and commercial tablets was found to be 100.50 % and 99.15 % respectively. The proposed method successfully resoled glibenclamide peak in the presence of its all type of degradation products which indicated stability-indicating property of the proposed method. These results indicated that the green chromatographic method could be successfully employed for routine analysis of glibenclamide in pure drug and various commercial formulations.