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片剂中醋酸甲羟孕酮的液相色谱测定法

Liquid chromatographic determination of medroxyprogesterone acetate in tablets.

作者信息

Fatmi A A, Williams G V, Hickson E A

机构信息

Reid-Rowell, Inc., Analytical Research and Development, Marietta, GA 30062.

出版信息

J Assoc Off Anal Chem. 1988 May-Jun;71(3):528-30.

PMID:2968977
Abstract

A reverse-phase liquid chromatographic method is described for the assay of medroxyprogesterone acetate in tablets. An octadecylsilane (C18) column with a mobile phase of methanol-0.01M dibasic ammonium phosphate (80 + 20 v/v, pH 7.2 +/- 0.1) and photometric detection at 254 nm separates medroxyprogesterone acetate from excipients. Detector responses were linear to concentrations of medroxyprogesterone acetate over the range 50-150 micrograms/mL (r = 0.999). Mean recovery of medroxyprogesterone acetate added to tablet excipients was 100.8%. Mean assay results were 101.3% (n = 3). The assay results are comparable to those obtained by the compendial liquid chromatographic method.

摘要

本文描述了一种用于测定片剂中醋酸甲羟孕酮的反相液相色谱法。采用十八烷基硅烷(C18)柱,以甲醇 - 0.01M磷酸氢二铵(80 + 20 v/v,pH 7.2 +/- 0.1)为流动相,并在254 nm处进行光度检测,可将醋酸甲羟孕酮与辅料分离。在50 - 150微克/毫升范围内,检测器响应与醋酸甲羟孕酮浓度呈线性关系(r = 0.999)。添加到片剂辅料中的醋酸甲羟孕酮的平均回收率为100.8%。平均测定结果为101.3%(n = 3)。该测定结果与药典液相色谱法获得的结果相当。

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