Abstract:
Validation of analytical methods is an important requirement in pharmaceutical analysis. Method validation provides documented evidence, and a high degree of assurance that an analytical method employed for a specific test is suitable for its intended use.
UV-VIS spectrophotometric methods are widely used recently for estimation of drug substances and drug products. Two methods were used for estimation of the anti-diabetic drug glibenclamide in bulk and pharmaceutical formulations using different solvents: chloroform for one method and a mixture of ethanol: water ( 5:1) for the other method.
In the British Pharmacopeia (BP) a UV-spectrophotometric method was used using methanol: HCl (0.1M methanolic HCl) as an identification test for glibenclamide.
The present research work discussed the validation of a UV estimation method for Glibenclamide in bulk and pharmaceutical formulations using 0.1M methanolic HCl as a solvent. The validated spectrophotometric method was proved to be simple, accurate and less expensive .The method , based on measurement of absorption at maximum wavelength of 300 nm, was validated with linearity, specificity, accuracy (recovery) and precision. Beer’s law was obeyed in the concentration range of 20-120 µg/ml having line equation y = 0.0065 × -0.0105 with correlation coefficient of 0.999. Results of the analysis were evaluated statistically.
