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HPLC 法测定霉酚酸有关物质及流动相pH 值的确定

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  • 1. 福建和泉生物科技有限公司,福建建阳354200;2. 福建省建阳武夷味精有限公司,福建建阳354200
张红飞(1983—),男,河南汤阴人,执业药师,主要从事质量管理工作,E-mail:zhf108@163.com.

Determination of mycophenolic acid related substances by HPLC and optimization of pH of mobile phrase

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  • 1. Fujian Hequan Biotechnology Co., Ltd., Jianyang 354200, China;
    2. Fujian Province Jianyang Wuyi MSG Co., Ltd., Jianyang 354200, China

摘要

为确定HPLC 法测定霉酚酸有关物质所用流动相的合理pH 值,配制pH 值为4.5 和5.5的流动相,采用Kromasil C18色谱柱(4.6 mm×200 mm,5 μm×100A)对霉酚酸进行有关物质的测定,对于同一个样品连续进样6 次,按照面积归一化法进行计算,以霉酚酸百分含量的相对标准偏差(RSD%)来确定流动相的合理pH 值。结果显示采用pH 值为4.5 的流动相进行霉酚酸有关物质的HPLC 测定,其测定结果稳定性好、灵敏度高、重现性好,可用于霉酚酸有关物质的测定。

本文引用格式

张红飞,林进南,连子龙,翁杨微,杨斌 . HPLC 法测定霉酚酸有关物质及流动相pH 值的确定[J]. 发酵科技通讯, 2015 , 44(4) : 48 -50 . DOI: 10.16774/j.cnki.issn.1674-2214.2015.04.013

Abstract

Mycophenolic acid related substance was analyzed by HPLC equipped with Kromasil C18 chromatogram column (4.6 mm×200 mm, 5 μm×100A) and the reasonable pH of mobile phase was determined. The same sample was analyzed for 6 times and determined according to area normalization method. The optimal pH of mobile phrase was determined on the basis of relative standard deviation (RSD%) of mycophenolic acid percentage. The method showed good stability, high sensitivity and good reproducibility when the pH value of the mobile phrase was 4.5.
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