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.
Alan : Fen Bilimleri ve Matematik
Dergi Türü : Uluslararası
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