Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities

J.A. BERTINATTO RODR´ÝGUEZ; M.F. DESIMONE; S.L. IGLESIAS; S.A. GIORGIERI; L.E. DIAZ

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Año: 2007 p. 305 - 308

0731-7085

Abstract A capillary zone electrophoretic (CZE) method has been developed for the determination of impurities (phosphyte and phosphate) in technicalgrade ibandronate, which is a potent nitrogen-containing bisphosphonate. Successful separation of the drug from the impurities was achieved using 1mMtetradecyl-trimethyl-ammonium bromide (TTAB) and 5mMpotassium 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 2g/mL and the limit of quantification (LOQ) was 7 g/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.