1. Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities.
- Author
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Rodríguez JA, Desimone MF, Iglesias SL, Giorgieri SA, and Diaz LE
- Subjects
- Chromates chemistry, Electrophoresis, Capillary instrumentation, Hydrogen-Ion Concentration, Ibandronic Acid, Phosphates analysis, Phosphites analysis, Potassium Compounds chemistry, Reproducibility of Results, Sensitivity and Specificity, Spectrophotometry, Ultraviolet, Trimethyl Ammonium Compounds chemistry, Bone Density Conservation Agents analysis, Diphosphonates analysis, Drug Contamination, Electrophoresis, Capillary methods
- Abstract
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 1mM tetradecyl-trimethyl-ammonium bromide (TTAB) and 5mM 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 microg/mL and the limit of quantification (LOQ) was 7 microg/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.
- Published
- 2007
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