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
in Chinese
| WPRIM
| ID: wpr-458788
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacist
Year:
2014
Type:
Article
Similar
MEDLINE
...
LILACS
LIS