期刊
ANALYTICAL LETTERS
卷 39, 期 9, 页码 1875-1890出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/00032710600721605
关键词
valdecoxib; robustness; experimental design; RP HPLC; SC-77852
A reversed-phase liquid chromatography method has been developed for the separation of valdecoxib and impurity SC-77852. The best results were achieved using a mobile phase-methanol: 1% water solution TEA (52 : 48 v/v), pH 7.35 (adjusted with 85% orthophosphoric acid), column temperature 24 degrees C. Separation was carried out on XTerra (TM) RP18 (150mm x 4,6 mm), particle size 5 mu m, flow rate 1ml/min, using detection on 220 nm. The method was statistically validated for its selectivity, linearity, precision (repeatability), and robustness. Quantitation and detection limits were determined for both valdecoxib and SC-77852. Method robustness was further evaluated by performing full factorial design experiment. Validated method was used for assay of valdecoxib and SC-77852 in Bextra (R) film-coated tablets.
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