Sekkat M, Fabre H, Simeon de Buochberg M, Mandrou B
Laboratoire de Chimie Analytique, Faculté de Pharmacie, Montpellier, France.
J Pharm Biomed Anal. 1989;7(7):883-92. doi: 10.1016/0731-7085(89)80010-x.
A simple, fast and reliable procedure for the determination of seven major aminoglycosides in commercial formulations (injections, capsules, eye drops, solutions and ointments) is presented. The aminoglycosides are separated on silica gel plates then located with ninhydrin and analysed in situ using a chromatogram spectrophotometer. Linearity tests, repeatability (relative standard deviation congruent to 3.5%) detection limits (60-200 ng) were satisfactory for all the compounds. Recovery data in pharmaceutical formulations (expressed as the percentage of the label claim) from thin-layer chromatography (TLC) and microbiological assays did not give any significant difference (P = 0.05); this result shows that TLC is a reliable method for the determination of aminoglycosides as the drug substance and in pharmaceutical formulations.
本文介绍了一种简单、快速且可靠的方法,用于测定市售制剂(注射剂、胶囊剂、滴眼剂、溶液剂和软膏剂)中的七种主要氨基糖苷类药物。氨基糖苷类药物在硅胶板上分离,然后用茚三酮定位,并使用色谱分光光度计进行原位分析。所有化合物的线性测试、重复性(相对标准偏差相当于3.5%)、检测限(60 - 200 ng)均令人满意。薄层色谱法(TLC)和微生物测定法在药物制剂中的回收率数据(以标示量的百分比表示)没有显著差异(P = 0.05);这一结果表明,TLC是测定原料药和药物制剂中氨基糖苷类药物的可靠方法。