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微乳液电动色谱在药物分析中的应用。

The use of microemulsion electrokinetic chromatography in pharmaceutical analysis.

作者信息

Miola M F, Snowden M J, Altria K D

机构信息

Pharmaceutical Development (Europe), GlaxoWellcome Research and Development, Ware, Herts, UK.

出版信息

J Pharm Biomed Anal. 1998 Dec;18(4-5):785-97. doi: 10.1016/s0731-7085(98)00217-9.

Abstract

The use of a single set of microemulsion electrokinetic chromatography (MEEKC) separation conditions has been assessed for its applicability in the analysis of a range of pharmaceutical compounds. Particular emphasis was placed on neutral or very hydrophobic compounds, which can be difficult to analyse by conventional capillary electrophoresis. The microemulsion employed for the majority of separations consisted of 0.81% w/w octane, 6.61% w/w 1-butanol, 3.31% w/w sodium dodecyl sulphate and 89.27% w/w 10 mM sodium tetraborate buffer. Good separations of methyl, ethyl, butyl and propyl hydroxybenzoates, and a range of ionic and neutral water soluble and insoluble compounds was achieved using a single set of separation conditions. A number of novel applications of MEEKC were developed included the simultaneous determination of the active components and preservatives in liquid formulation and determination of drug related impurities. Improved performance was obtained through use of internal standards and preparation of the samples dissolved in the microemulsion solution. Validation aspects such as linearity, repeatability, accuracy, injection precision and sensitivity were successfully assessed.

摘要

已评估了使用单一的微乳液电动色谱(MEEKC)分离条件对一系列药物化合物进行分析的适用性。特别强调了中性或非常疏水的化合物,这些化合物用传统毛细管电泳分析可能会很困难。大多数分离所采用的微乳液由0.81%(w/w)辛烷、6.61%(w/w)正丁醇、3.31%(w/w)十二烷基硫酸钠和89.27%(w/w)10 mM硼酸钠缓冲液组成。使用单一的分离条件实现了对甲基、乙基、丁基和丙基羟基苯甲酸酯以及一系列离子型和中性水溶性及不溶性化合物的良好分离。开发了MEEKC的一些新应用,包括同时测定液体制剂中的活性成分和防腐剂以及测定药物相关杂质。通过使用内标和制备溶解在微乳液溶液中的样品,性能得到了改善。成功评估了线性、重复性、准确性、进样精密度和灵敏度等验证方面。

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