格列本脲片剂含量测定方法的建立

L. H. Leleka, S. O. Vasuik
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引用次数: 0

摘要

的目标。建立与2,3-二氯-1,4-萘醌反应定量测定格列本脲片剂的分光光度法并进行验证。材料和方法。本研究采用药典纯度的物质格列本脲,选择“CFA”资格的2,3-二氯-1,4-萘醌片-“CFA”为试剂,作为溶剂-二甲基甲酰胺(DMF)“CFA”。本研究使用的分析设备如下:分光光度计“Specord-200”(德国耶拿分析公司),水浴“MEMMERT WNB7”,实验室电子秤RADWAG XA 210。4Y, a类实验室测量容器。建立了一种在DMF介质中与2,3-二氯-1,4-萘醌反应测定格列本脲片剂中格列本脲含量的简便分光光度法。吸收峰在489 ~ 491 nm处。检出限为10.9 μg/ml,具有足够的灵敏度。在13.7 ~ 27.4 mg/100 ml的浓度范围内,符合光吸收的基本规律。在建立方法的过程中,确定了以下验证特性:专属性、线性、精密度、正确性和稳健性。根据乌克兰国家药典的要求,建立了格列本脲定量测定方法并进行了验证。结果表明,该方法简单易行,具有线性、收敛性和鲁棒性等特点,可用于实验室药品质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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 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.
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