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液相色谱法测定片剂中的甲基多巴及甲基多巴-氢氯噻嗪复方制剂:协作研究

Liquid chromatographic determination of methyldopa and methyldopa-thiazide combinations in tablets: collaborative study.

作者信息

Ting S

出版信息

J Assoc Off Anal Chem. 1984 Nov-Dec;67(6):1118-20.

PMID:6520085
Abstract

A reverse phase liquid chromatographic method for the determination of methyldopa, methyldopa-hydrochlorothiazide, and methyldopachlorothiazide in tablets was collaboratively studied by 8 laboratories. Each collaborator received 20 samples that included drug substance, synthetic and commercial tablet compositions. The overall repeatability and reproducibility standard deviations for commercial tablets were 1.11 and 1.75% for methyldopa, 0.96 and 1.62% for chlorothiazide, and 1.21 and 2.15% for hydrochlorothiazide, respectively. The overall recoveries of methyldopa, chlorothiazide, and hydrochlorothiazide added to synthetic tablets were 100.78, 100.70, and 101.34%, respectively. The method has been adopted official first action.

摘要

8个实验室合作研究了一种用于测定片剂中甲多巴、甲多巴-氢氯噻嗪和甲多巴氯噻嗪的反相液相色谱法。每位合作者收到20个样品,包括原料药、合成片剂和市售片剂组合物。市售片剂中甲多巴的总体重复性和再现性标准偏差分别为1.11%和1.75%,氯噻嗪为0.96%和1.62%,氢氯噻嗪为1.21%和2.15%。添加到合成片剂中的甲多巴、氯噻嗪和氢氯噻嗪的总体回收率分别为100.78%、100.70%和101.34%。该方法已被官方首次采用。

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