High-performance liquid chromatographic determination of polysorbate 80 in pharmaceutical suspensions

被引：35

作者：

Hu, M ^{[1
]}

Niculescu, M ^{[1
]}

Zhang, XM ^{[1
]}

Hui, A ^{[1
]}

机构：

[1] Novex Pharma, Richmond Hill, ON L4C 5H2, Canada

来源：

JOURNAL OF CHROMATOGRAPHY A | 2003年 / 984卷 / 02期

关键词：

polysorbate; 80;

D O I：

10.1016/S0021-9673(02)01849-6

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

A quick HPLC method is reported for the analysis of polysorbate 80 in, pharmaceutical suspensions. A typical pharmaceutical suspension was mixed with dilute potassium hydroxide, and heated at 40 degreesC for 6 h. This procedure resulted in quantitative hydrolysis of polysorbate 80 to release oleic acid. A quick HPLC procedure was used to analyze the hydrolyzed samples without further sample treatment. Polysorbate 80 USP, treated in the same way as the pharmaceutical suspensions, was used as standard. Full validation tests were carried out and the validation studies demonstrated that this method is suitable for accurate and reproducible analysis of polysorbate 80 in pharmaceutical suspensions. (C) 2002 Elsevier Science B.V. All rights reserved.

引用

页码：233 / 236

页数：4

共 20 条

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