Quantitative determination of anti-tumor agent bis(4-fluorobenzyl)trisulfide, fluorapacin and its pharmaceutical preparation by high-performance liquid chromatography |
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Authors: | Bao Yimei He Yuyu Xu Xiaoying Mo Xiaopeng Xu Xiao Wang Xiaobo An Haoyun |
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Institution: | ACEA Bio (Hangzhou) Co., Ltd., Building 3, West Lake Technical & Economic Park, 2# Xiyuan 5 Road, Sandun, Hangzhou 310030, China. |
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Abstract: | 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 microm) 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 microg/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. |
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Keywords: | Fluorapacin Pharmaceutical preparation Analytical method Isocratic HPLC Quantitative determination |
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