Determination of 1-Chloroethyl Cyclohexyl Carbonate in Candesartan Cilexetil Tablets by GC-MS/MS
10.13748/j.cnki.issn1007-7693.20224082
- VernacularTitle:GC-MS/MS测定坎地沙坦酯片中基因毒性杂质1-氯乙基环己基碳酸酯
- Author:
Xiaoqin LIU
1
;
Xiao GU
1
;
Weifang NI
2
;
Qiaofeng TAO
2
;
Jinqi ZHENG
2
Author Information
1. Zhejiang Institute for Food and Drug Control, Hangzhou 310000, China；Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration, Hangzhou 310000, China
2. Zhejiang Institute for Food and Drug Control, Hangzhou 310000, China；Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration, Hangzhou 310000, China；Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, Hangzhou 310000, China
- Publication Type:Journal Article
- Keywords:
candesartan cilexetil tablets ；1-chloroethyl cyclohexyl carbonate；GC-MS/MS；genotoxic impurity
- From:
Chinese Journal of Modern Applied Pharmacy
2024;41(9):1238-1241
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE :To establish a GC-MS/MS analytical method for the determination of 1-chloroethyl cyclohexyl carbonate in candesartan cilexetil tablets.
METHODS
The analytical column was DB-5MS(30 m×0.25 mm, 0.25 μm). The column temperature was maintained at 80 ℃, then was raised to 300 ℃ at the rate of 20 ℃·min–1 and was maintained for 5 min. Helium was used as carrier gas, and its flow rate was 1.0 mL·min–1. The detection was achieved in multiple reaction monitoring mode.
RESULTS
The calibration curve of 1-chloroethyl cyclohexyl carbonate had good linearity in the concentration range of 4.4−437.8 ng·mL–1. The limits of quantification and detection were 4.4 and 2.2 ng·mL–1, respectively. The average recovery was 95.6%(RSD=6.3%, n=9).
CONCLUSION
This method has satisfactory convenience, good sensitivity and high accuracy, and it is suitable for the determination of 1-chloroethyl cyclohexyl carbonate in candesartan cilexetil tablets.
