阿莫西林碘量测定方法在纯物质和药物制剂定量分析中的验证

Y. Serdiukova, O. Kolisnyk, Т. О. Tomarovska, S. M. Poluian, Z. Shovkova, O. H. Pohosian
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摘要

本工作的目的是验证一种简单、快速的碘量测定方法,用于纯物质和药物制剂中阿莫西林的定量测定。材料和方法。这个过程包括使用胡萝卜酸钾(KHSO5)作为氧化剂。该分析是基于青霉素被KHSO5氧化为相应的s -氧化物的定量。阿莫西林与分析试剂的相互作用是化学计量的。采用间接碘量法定量测定阿莫西林的主要物质。按照乌克兰国家药典进行验证。精密度、准确度、检出限和定量限在80 ~ 120%的浓度范围内均可接受,相关系数为0.999。阿莫西林纯物的LOD和LOQ分别为4.91%和14.73%。以相对标准偏差(RSD)计算的精密度小于0.8%,准确度(δ,相对误差)优于0.4%。通过统计和回收率研究验证了该方法的有效性。阿莫西林药物制剂的RSD≥1.93%,δ≥1.62%。所获得的数据显示与证书结果可接受的一致性,因此所建议的程序可用于药物制剂中阿莫西林的测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Validation of Amoxicillin iodometric procedure in quantitative analysis of pure substance and medical preparation
The aim of the work is to validate a simple and rapid iodometric procedure for the quantitative determination of amoxicillin in pure substance and medicinal preparation using potassium caroate as analytical reagent. Materials and methods. The procedure involves the use of potassium caroate (KHSO5) as an oxidant. The assay is based on the quantitative penicillin oxidation by KHSO5 to the corresponding S-oxide. The interaction between amoxicillin and analytical reagent is stoichiometric. Indirect iodometric method is used for the quantitative determination of amoxicillin main substance. The validation procedure was performed according to the State Pharmacopeia of Ukraine. Results. The precision, accuracy, limit of detection (LOD), and limit of quantitation (LOQ) are accepted over the concentration range of 80–120 % with a correlation coefficient of 0.999. LOD and LOQ were found to be 4.91 % and 14.73 % for amoxicillin pure substance respectively. The precision calculated as the relative standard deviation (RSD) was less than 0.8 % and accuracy (δ, relative error) was better than 0.4 %. The proposed method was validated statistically and through recovery studies. For Amoxicillin medical preparation RSD ≥1.93 % and δ ≥ 1.62 %. Conclusions. The obtained data showed acceptable agreement with the certificate results, so the proposed procedure can be used for the assay of amoxicillin in medicinal preparation.
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