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药物制剂中氨基糖苷类的测定——II. 高效液相色谱法

Determination of aminoglycosides in pharmaceutical formulations--II. High-performance liquid chromatography.

作者信息

Fabre H, Sekkat M, Blanchin M D, Mandrou B

机构信息

Faculté de Pharmacie, Montpellier, France.

出版信息

J Pharm Biomed Anal. 1989;7(12):1711-8. doi: 10.1016/0731-7085(89)80185-2.

DOI:10.1016/0731-7085(89)80185-2
PMID:2490559
Abstract

A post-column derivatization procedure using OPA and fluorescence detection has been used for the determination of seven aminoglycosides (dibekacin, framycetin, kanamycin, netilmicin, sisomicin, tobramycin and gentamicin) in commercial pharmaceutical formulations. The linearity, precision and detection limits were satisfactory. Recoveries from eye drops, ointments, injections and capsules were comparable (P = 0.05) to those obtained with TLC or microbiological assays. A ruggedness test showed that the method was not sensitive to minor variations in the mobile phase composition, post-column derivatization system or detection wavelength.

摘要

采用邻苯二甲醛(OPA)柱后衍生化程序和荧光检测法测定市售药物制剂中的七种氨基糖苷类药物(双去氧卡那霉素、新霉素、卡那霉素、奈替米星、西索米星、妥布霉素和庆大霉素)。线性、精密度和检测限均令人满意。滴眼液、软膏、注射剂和胶囊的回收率与薄层色谱法(TLC)或微生物测定法的回收率相当(P = 0.05)。耐用性测试表明,该方法对流动相组成、柱后衍生化系统或检测波长的微小变化不敏感。

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