期刊
JOURNAL OF SEPARATION SCIENCE
卷 28, 期 2, 页码 137-143出版社
WILEY-V C H VERLAG GMBH
DOI: 10.1002/jssc.200401785
关键词
preservatives; parabens; benzyl alcohol; phenol; m-cresol; thimerosal; chlorobutanol; pharmaceutical analysis; method validation
Preservatives are used to protect pharmaceutical formulations from microbial attack during the period of administration to the patient. Because of their biological activity, preservatives have to be identified and assayed according to the same rules as apply to active components. A number of methods for separation of preservatives are reported, to account for the heterogeneity of their chemical structures. A capillary electrophoretic method was devised for simple and simultaneous qualification and quantification of the preservatives most often included in pharmaceuticals, such as benzyl alcohol, parabens, phenol, m-cresol, chlorobutanol, thimerosal. After systematic method development, the electrophoretic conditions were defined as: 50 mM borate buffer pH 9.0 containing 20 mM SIDS. Separations were performed at a temperature of 20degreesC and with detection at 214 nm. Preservatives under examination can be analyzed within a 10 min run. The method was successfully validated and applied to the determination of preservatives in a number of pharmaceuticals. Results from the CE method were compared with those from reference methods.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据