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.
Objective: A new spectrophotometric method for the gliclazide quantitation in dosage forms has been developedMaterial and Method: The subjects of the study were modified-release tablets ("Diaglizide" 80 mg, "Diaglizide MR" 60 mg, "Diaglizide MR" 30 mg, "Diabeton" MR 60 mg, "Gliklada" 60 mg). As a reagent, bromocresol green in acetone was used. Analytical equipment: spectrophotometer Specord 200, electronic scales АВТ-120-5DM.Result and Discussion: It has been experimentally determined that gliclazide reacts with bromocresol green in acetone medium at room temperature to form a yellow product with maximum absorption at 411 nm. The method was validated for linearity, accuracy, precision, and robustness. The agent’s optimal concentration was established and the stability of the investigated solutions was checked by measuring their optical density for 30 minutes. Subordination of Beer's law is observed in the range of 62.00 - 94.00 mg/100 ml. The limit of detection is 4.02∙10-6 g/ml, which indicates a high sensitivity of the reaction. The proposed method is validated according to the requirements of the State Pharmacopoeia of Ukraine. The results of the study show that the developed method is simple and affordable to implement and can be used to determine gliclazide in drugs in laboratories for quality control of dosage forms.
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