Quantitative determination of anti-tumor agent bis(4-fluorobenzyl)trisulfide, fluorapacin and its pharmaceutical preparation by high-performance liquid chromatography.
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.
Bao
Yimei
Y
ACEA Bio (Hangzhou) Co., Ltd., Building 3, West Lake Technical & Economic Park, 2# Xiyuan 5 Road, Sandun, Hangzhou 310030, China.
He
Yuyu
Y
Xu
Xiaoying
X
Mo
Xiaopeng
X
Xu
Xiao
X
Wang
Xiaobo
X
An
Haoyun
H
D000970:Antineoplastic Agents / Q000032:analysis* / Q000737:chemistry; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D000431:Ethanol / Q000032:analysis / Q000737:chemistry; D005464:Fluorobenzenes / Q000032:analysis* / Q000737:chemistry; D005990:Glycerol / Q000031:analogs & derivatives / Q000032:analysis / Q000737:chemistry; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry; D011786:Quality Control; D015203:Reproducibility of Results; D013440:Sulfides / Q000032:analysis* / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods; D024502:alpha-Tocopherol / Q000032:analysis / Q000737:chemistry
D000970:Antineoplastic Agents; D005464:Fluorobenzenes; D004364:Pharmaceutical Preparations; D013440:Sulfides; C528265:fluorapacin; D000431:Ethanol; C000515:cremophor EL; D024502:alpha-Tocopherol; D005990:Glycerol