Quantitative determination of anti-tumor agent bis(4-fluorobenzyl) trisulfide, fluorapacin and its pharmaceutical preparation by high-performance liquid chromatography

被引：6

作者：

Bao, Yimei ^{[2
]}

He, Yuyu ^{[2
]}

Xu, Xiaoying ^{[2
]}

Mo, Xiaopeng ^{[2
]}

Xu, Xiao ^{[1
]}

Wang, Xiaobo ^{[1
]}

An, Haoyun ^{[1
]}

机构：

[1] ACEA Biosci Inc, San Diego, CA 92121 USA

[2] ACEA Bio Hangzhou Co Ltd, Hangzhou 310030, Peoples R China

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2008年 / 46卷 / 01期

关键词：

fluorapacin; pharmaceutical preparation; analytical method; isocratic; HPLC; quantitative determination;

D O I：

10.1016/j.jpba.2007.09.018

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A simple isocratic and stability-indicating HPLC method was developed and validated for the quantitative determination of anti-tumor agent fluorapacin and its pharmaceutical preparation. A Spherisorb ODS II C-18 (250 mm x 4.6 mm, 5 mu m) column was eluted with a mobile phase consisting of acetonitrile/water (85:15, v/v). The analyses were performed at 40 +/- 1 degrees C with a flow rate of 1.0 mL/min and UV detection at 218 nm. The calibration curve was linear over a concentration range of 160-240 mu g/mL with the correlation coefficient of 0.9997. The LOD and LOQ were determined to be 1.4 and 7.0 ng/mL, respectively. Average recoveries were 98.27% and 100.40% for fluorapacin API and its drug product with corresponding relative standard deviations (R.S.D.) of 0.41% and 0.30%, respectively. Good repeatability (precision and intermediate precision), accuracy and tolerability were obtained with R.S.D. of <1.0%. This specific and reliable method has been successfully applied for quality control of fluorapacin API and drug product. (c) 2007 Elsevier B.V. All rights reserved.

引用

页码：206 / 210

页数：5

共 19 条

[1] Synthesis and anti-tumor evaluation of new trisulfide derivatives [J].