Development and Validation of Analytical Method for Qualitative and Quantitative Determination of Glibenclamide in Different Brands of Tablet Dosage form Using UV-Visible Spectroscopy

Abstract

This paper describes a methodology to develop a new method for qualitative and quantitative determination of glibenclamide (GLB) in three brands of GLB tablets. We validated the developed method for linearity, accuracy, precision, limit of detection (LOD) and limit of quantification (LOQ) according to the guidelines of the International Conference on Harmonization. Finally, we estimated the qualitative and quantitative amount of GLB in three brands of GLB tablets using validated method. A non significant difference was observed in the dissolution profiles of GLB in these tablets. Validation of developed method showed that a linear relationship (r 2 >0.999) was observed at maximum absorbance (λ max) at 229.5 nm with concentration range of 3-15 μg/ml GLB. Accuracy of developed method was found to be within the limit of 95-105%. The percent relative standard deviation (%RSD) and percent relative error (%RE) for precision was found to be <3%. In three brands of GLB tablets, values of LOD and LOQ were 10 ng/ml and 35 ng/ml respectively. We also found that the amount of GLB in each tablet corresponded to the requirements of 95-105% of the label claimed in tablet. From the results of validation of developed method, it concluded that developed method showed satisfactory linearity, precision and accuracy for analysis of active ingredients of commercially available pharmaceutical products.