Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities.
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.
Rodríguez
J A Bertinatto
JA
Cátedra de Química Analítica Instrumental, Facultad de Farmacia y Bioquímica, Universidad de Buenos Aires, Buenos Aires, Argentina.
Desimone
M F
MF
Iglesias
S L
SL
Giorgieri
S A
SA
Diaz
L E
LE
D050071:Bone Density Conservation Agents / Q000032:analysis*; D002840:Chromates / Q000737:chemistry; D004164:Diphosphonates / Q000032:analysis*; D004340:Drug Contamination; D019075:Electrophoresis, Capillary / Q000295:instrumentation / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D000077557:Ibandronic Acid; D010710:Phosphates / Q000032:analysis; D017905:Phosphites / Q000032:analysis; D017680:Potassium Compounds / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet; D050337:Trimethyl Ammonium Compounds / Q000737:chemistry
D050071:Bone Density Conservation Agents; D002840:Chromates; D004164:Diphosphonates; D010710:Phosphates; D017905:Phosphites; D017680:Potassium Compounds; D050337:Trimethyl Ammonium Compounds; C027373:potassium chromate(VI); D000077557:Ibandronic Acid; C009410:tetradecyltrimethylammonium