药品中替硝唑的分光光度测定方法的建立与验证

Shukhrat Gaibullaev, Feruza Berdymuradov, K. Zakhidov, D. Aronbaev, Sergey D. Aronbaev
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引用次数: 0

摘要

建立了一种简便、经济的紫外分光光度法定量测定替硝唑的方法。所选波长的最大吸收λ max。在pH = 6.86的磷酸盐缓冲液中,替硝唑溶液为317.3 nm。在3.0 ~ 30 μg / ml浓度范围内,校正图在所选波长处呈线性关系,符合朗伯-布格-比尔定律,相关系数至少为0.992。对药物中替硝唑的提取率进行了研究,其提取率为97.9% ~ 100.4%,证实了该方法的准确性。对所建立的分光光度法进行了计量评价,结果表明该方法具有良好的重现性和准确性,可用于不同厂家单组分和多组分药品中替硝唑的含量测定。测定替硝唑的相对误差不超过2%。对所得数据进行统计处理表明,该方法可成功用于替硝唑在实验室的稳定性常规分析,为药品质量控制提供依据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DEVELOPMENT AND VALIDATION OF A SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF TINIDAZOLE IN PHARMACEUTICAL PRODUCTS
A simple and economical UV spectrophotometric method for the quantitative assessment of tinidazole has been developed and tested. Selected wavelength of maximum absorption λ max . for a solution of tinidazole in phosphate buffer (pH = 6.86) is 317.3 nm. The calibration graph shows linearity at the selected wavelength and obeys the Lambert-Bouguer-Beer law in the concentration range of 3.0-30 μg / ml with a correlation coefficient of at least 0.992. Studies have been conducted on the extraction of tinidazole in pharmaceuticals, which is 97.9 - 100.4%, which confirms the accuracy of the proposed method. The metrological evaluation of the developed spectrophotometric method showed good reproducibility and accuracy of the determination of tinidazole in mono- and multicomponent pharmaceutical products from various manu-facturers. The relative error in the determination of tinidazole does not exceed 2%. Statistical processing of the data obtained shows that the proposed method can be successfully applied for routine analysis of the stability of tinidazole in laboratories for quality control of drugs.
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