Determination of 4-Methyl-N-(4-(pyridin-3-yl) pyrimidin-2-yl) benzene-1, 3-diamine in Imatinib Mesylate by LC-MS/MS / 中国药师
China Pharmacist
; (12): 2030-2032, 2014.
Article
en Zh
| WPRIM
| ID: wpr-458788
Biblioteca responsable:
WPRO
ABSTRACT
Objective:To establish a method for the determination of 4-methyl-N-(4-(pyridin-3-yl) pyrimidin-2-yl) benzene-1,3-diamine as an impurity in the preparation of imatinib mesylate. Methods: An LC-MS/MS method was used with ESI ion source con-trolled by a positive-ion mode. The MRM mode was performed with 278. 1/106. 1 as the scanning and ion-pair. Acetonitrile solution containing ammonium formate and formic acid was used with gradient elution. Results:The linear range was 1. 572~47. 160 ng/ml(r=0. 999 7). The detection limit was 0. 002 1ng and the limit of quantitation was 0. 006 8ng. The average recovery was 100. 9% with RSD of 2. 88. The results of specificity, solution stability, repeatability and durability all met the specification. Conclusion:The meth-od is sensitive, accurate and special in the determination of 4-methyl-N-(4-(pyridin-3-yl) pyrimidin-2-yl) benzene-1,3-diamine in imatinib mesylate.
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Base de datos:
WPRIM
Idioma:
Zh
Revista:
China Pharmacist
Año:
2014
Tipo del documento:
Article