Determination of 1-Chloroethyl Cyclohexyl Carbonate in Candesartan Cilexetil Tablets by GC-MS/MS

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.