Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities.
J Pharm Biomed Anal
; 44(1): 305-8, 2007 May 09.
Article
de En
| MEDLINE
| ID: mdl-17382505
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.
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Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Contamination de médicament
/
Électrophorèse capillaire
/
Diphosphonates
/
Agents de maintien de la densité osseuse
Type d'étude:
Diagnostic_studies
Langue:
En
Journal:
J Pharm Biomed Anal
Année:
2007
Type de document:
Article
Pays d'affiliation:
Argentine