Affiliation:
1. Open Joint-Stock Ukrainian - Belgian Chemical Enterprise InterChem
2. A.V. Bogatsky Physico-chemical Institute of the National Academy of Sciences of Ukraine
Abstract
The cleaning procedure must be validated, so special attention must be devoted to the methods used for determination of trace amounts of drugs. A rapid, sensitive, and specific reverse phase high-performance liquid chromatographic (HPLC) method was developed for the quantitative determination of fenspiride hydrochloride residues on pharmaceutical manufacturing equipment surfaces. The calibration curve was linear over a concentration range from 1.0 to 100.0 μg/ml with a correlation coefficient of 0.99994. The detection limit and quantitation limit were 0.41 μg/ml and 1.25 μg/ml, respectively. The developed method was validated with respect to specificity, linearity, limit of detection, accuracy and precision.
Publisher
Taras Shevchenko National University of Kyiv
Reference12 articles.
1. Guide to inspections validation of cleaning processes, U.S. Food and Drug Administration, Office of Regulatory Affairs, Washington, DC. 1993.
2. Fourman GL, Mullen MV. Determining cleaning validation acceptance limits for pharmaceutical manufacturing operations. Pharm Technol. 1993:17:54–60.
3. Folisi V, Braga F, and Paracchini S. Spectrophotometric determination of fenspiride chlorhydrate. Bollettino chimico farmaceutico. 1976;115(5): 390-394.
4. Sauveur C, Baune A, Vergnes N, Jeanniot J. The determination of fenspiride in human plasma and urine by liquid chromatography with electrochemical or ultraviolet detection. Journal of Pharmaceutical and Biomedical Analysis 1989;7(12):1799-1804. https://doi.org/10.1016/0731-7085(89)80196-7
5. Dumasia M, Houghton E, Hyde W, Greulich D, Nelson T, Peterson J. Detection of fenspiride and identification of in vivo metabolites in horse body fluids by capillary gas chromatography–mass spectrometry: administration, biotransformation and urinary excretion after a single oral dose. Journal of Chromatography B 2002;767(1):131-144. https://doi.org/10.1016/s0378-4347(01)00556-4
Cited by
2 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献