کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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1224328 | 967918 | 2007 | 4 صفحه PDF | دانلود رایگان |
A capillary zone electrophoretic (CZE) method has been developed for the determination of impurities (phosphyte and phosphate) in technical-grade ibandronate, which is a potent nitrogen-containing bisphosphonate. Successful separation of the drug from the impurities was achieved using 1 mM tetradecyl-trimethyl-ammonium bromide (TTAB) and 5 mM potassium chromate (pH 10.0) as background electrolyte with an indirect detection at 254 nm. The optimised method was validated for specificity, precision, linearity and accuracy. The limit of detection (LOD) was 2 μg/mL and the limit of quantification (LOQ) was 7 μg/mL for both phosphyte and phosphate. The developed CZE method used to determine phosphyte and phosphate as bisphosphonates impurities can be used to evaluate the quality of regular production samples of ibandronate.
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 44, Issue 1, 9 May 2007, Pages 305–308