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通过固相萃取和反相液相色谱法测定药物剂型中的脂溶性维生素。

Determination of fat-soluble vitamins in a pharmaceutical dosage form by solid-phase extraction and reversed-phase liquid chromatography.

作者信息

Savolainen K E, Pynnönen K M, Lapinjoki S P, Vidgren M T

机构信息

Orion Corporation, Ltd., Orion Pharmaceutica, Kuopio, Finland.

出版信息

J Pharm Sci. 1988 Sep;77(9):802-3. doi: 10.1002/jps.2600770918.

DOI:10.1002/jps.2600770918
PMID:2852248
Abstract

A rapid and precise method for the determination of fat-soluble vitamins from a water-based multivitamin mixture was developed utilizing solid-phase extraction and reversed-phase high-performance liquid chromatography (HPLC). Cholecalciferol, alpha-tocopherol acetate, and retinol palmitate were extracted in a single stage from the matrix using Bond Elut C18 columns. The vitamins were then chromatographed on a Hypersil 5-microns C18 column, using a water:methanol gradient, and quantified simultaneously using individual UV absorption maxima. The recovery of added analytes varied from 92.6 to 100.6%. The assay coefficient of variation was 1.7-2.7%. The sample preparation method and HPLC assay described here are practical for pharmaceutical quality control purposes.

摘要

利用固相萃取和反相高效液相色谱法(HPLC),开发了一种从水性多种维生素混合物中快速、精确测定脂溶性维生素的方法。使用Bond Elut C18柱,在单个步骤中从基质中提取胆钙化醇、α-生育酚乙酸酯和视黄醇棕榈酸酯。然后,将这些维生素在Hypersil 5微米C18柱上进行色谱分析,使用水:甲醇梯度,并利用各个紫外吸收最大值同时进行定量。添加分析物的回收率在92.6%至100.6%之间。测定变异系数为1.7 - 2.7%。本文所述的样品制备方法和HPLC测定法适用于药物质量控制目的。

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