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原料药及固体剂型中灰黄霉素的高效液相色谱分析:杂质与代谢物的分离

High-performance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: separation of impurities and metabolites.

作者信息

Townley E, Roden P

出版信息

J Pharm Sci. 1980 May;69(5):523-6. doi: 10.1002/jps.2600690512.

DOI:10.1002/jps.2600690512
PMID:7381735
Abstract

A high-performance liquid chromatographic (HPLC) system, consisting of a methanol-water (3:2 v/v) mobile phase and a Zorbax CN column with m-phenylphenol as the internal standard, was utilized to determine the purity of griseofulvin bulk drug substance, to assay griseofulvin in powders, tablets, capsules, and boluses, and to separate griseofulvin from its metabolites. The method was tested on commercial griseofulvin samples, griseofulvin tablets, and a mixture of griseofulvin and its metabolites. The HPLC method is compared to a GLC method.

摘要

采用高效液相色谱(HPLC)系统,其流动相为甲醇 - 水(3:2 v/v),以间苯二酚为内标物的Zorbax CN柱,用于测定灰黄霉素原料药的纯度,分析粉末、片剂、胶囊和大丸剂中的灰黄霉素,并将灰黄霉素与其代谢物分离。该方法在市售灰黄霉素样品、灰黄霉素片剂以及灰黄霉素及其代谢物的混合物上进行了测试。将HPLC方法与气相色谱(GLC)方法进行了比较。

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