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

Abstract

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

Keywords

• glibenclamide
• 2
• 3-dichloro-1
• 4-naphthoquinone
• spectrophotometry
• validation study
• quantitative determination
• pharmaceutical preparations
• substance
• state pharmacopoeia of ukraine (spu)