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  • Title: Quantitative determination of anti-tumor agent bis(4-fluorobenzyl)trisulfide, fluorapacin and its pharmaceutical preparation by high-performance liquid chromatography.
    Author: Bao Y, He Y, Xu X, Mo X, Xu X, Wang X, An H.
    Journal: J Pharm Biomed Anal; 2008 Jan 07; 46(1):206-10. PubMed ID: 17964749.
    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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