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多种维生素 - 矿物质药物制剂中叶酸的快速特异性高效液相色谱测定法

Rapid and specific high-pressure liquid chromatographic assay for folic acid in multivitamin-mineral pharmaceutical preparations.

作者信息

Tafolla W H, Sarapu A C, Dukes G R

出版信息

J Pharm Sci. 1981 Nov;70(11):1273-6. doi: 10.1002/jps.2600701123.

Abstract

A high-pressure liquid chromatographic assay for folic acid in multivitamin-mineral pharmaceutical formulations was developed. The internal standard solution used for sample extraction contained a chelating agent, pentetic acid, for prevention of metal ion-catalyzed degradation of folic acid in th prepared samples. Samples were chromatographed using a paired-ion mobile phase (water-methanol, approximately 76:24; 0.015 M phosphate buffer, pH 7.0; and 0.3% tetrabutylammonium hydroxide) on a column packed with octadecylsilane bonded to microparticulate silica gel. Sample preparation was rapid, and total chromatographic time was approximately 20 min. The method was accurate, precise, and highly specific. Folic acid and the internal standard, methylparaben, were separated from other tablet components and a number of potential impurities and degradation products of folic acid.

摘要

开发了一种用于多种维生素-矿物质药物制剂中叶酸的高压液相色谱测定法。用于样品提取的内标溶液含有螯合剂喷替酸,以防止所制备样品中金属离子催化的叶酸降解。使用配对离子流动相(水-甲醇,约76:24;0.015 M磷酸盐缓冲液,pH 7.0;和0.3%氢氧化四丁基铵)在填充有键合到微粒硅胶上的十八烷基硅烷的柱上对样品进行色谱分析。样品制备快速,总色谱分析时间约为20分钟。该方法准确、精密且具有高度特异性。叶酸和内标对羟基苯甲酸甲酯与其他片剂成分以及叶酸的许多潜在杂质和降解产物分离。

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