Development of a Quantitative Determination Method for Polysorbate 80 in Biologicals by Size-Exclusion High-Performance Liquid Chromatography

IF 0.8 4区医学 Q4 CHEMISTRY, MEDICINAL

Pharmaceutical Chemistry Journal Pub Date : 2024-04-17 DOI:10.1007/s11094-024-03110-4

O. B. Rounova, M. G. Korotkov, O. B. Ustinnikova

引用次数: 0

Abstract

Aquantitative determination method for polysorbate 80 in biological medicinal preparations using size-exclusion chromatography with UV detection was developed. OASIS HLB solid-phase extraction cartridges were used to extract polysorbate 80 from formulations with high protein concentrations. The HPLC separation was performed using a TSKgel G2000SWX column in isocratic mode. The mobile phase was phosphate buffer (0.1 M) containing sodium sulfate (0.1 M) and sodium dodecyl sulfate (0.1%). The developed method could be used for quantitative determination of polysorbate 80 in biological medicinal products.

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利用尺寸排阻高效液相色谱法开发生物制品中聚山梨醇酯 80 的定量检测方法

采用尺寸排阻色谱-紫外检测法，建立了生物药剂中聚山梨酯 80 的定量测定方法。使用 OASIS HLB 固相萃取柱从蛋白质浓度较高的制剂中萃取聚山梨醇酯 80。在等度模式下，使用 TSKgel G2000SWX 色谱柱进行高效液相色谱分离。流动相为含硫酸钠（0.1 M）和十二烷基硫酸钠（0.1%）的磷酸盐缓冲液（0.1 M）。所建立的方法可用于生物药品中聚山梨酯80的定量检测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Chemistry Journal CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

1.30

自引率

22.20%

发文量

226

审稿时长

3-8 weeks

期刊介绍： Pharmaceutical Chemistry Journal is a monthly publication devoted to scientific and technical research on the creation of new drugs and the improvement of manufacturing technology of drugs and intermediates. International contributors cover the entire spectrum of new drug research, including: methods of synthesis; results of pharmacological, toxicological, and biochemical studies; investigation of structure - activity relationships in prediction of new compounds; methods and technical facilities used; and problems associated with the development of ecologically safe and economically feasible methods of industrial production. In addition, analytical reviews of the international literature in the field provide coverage of the most recent developments around the world. Pharmaceutical Chemistry Journal is a translation of the Russian journal Khimiko-Farmatsevticheskii Zhurnal. The Russian Volume Year is published in English from April. All articles are peer-reviewed.