Development of a method for the quantitative determination of glibenclamide in tablets

Aim. To develop and validate a spectrophotometric technique for quantitative determination of glibenclamide in tablets by reaction with 2,3-dichloro-1,4-naphthoquinone. Materials methods. In the study, substance pharmacopoeial purity was used, – “Maninil” 5 mg “Glibenclamid-Zdorovye” mg, 2,3-dichloro-1,4-naphthoquinone “CFA” qualification chosen as reagent, solvent dimethylformamide (DMF) “CFA”. The following analytical equipment used research: spectrophotometer “Specord-200” (Analytic Jena AG, Germany), water bath “MEMMERT WNB7”, laboratory electronic scales RADWAG XA 210. 4Y, measuring vessels class A. Results. A new, simple method DMF medium developed. absorption maximum at 489–491 nm. value detection limit is 10.9 μg/ml, which indicates sufficient sensitivity reaction. Subordination to basic law light within limits concentrations 13.7–27.4 mg/100 ml. process developing methodology, validation characteristics were determined: specificity, linearity, precision, correctness, robustness. Conclusions. methodology developed validated according requirements State Pharmacopoeia Ukraine. It has been proven that simple, accessible, such convergence robustness can be application laboratories quality control medicinal products.