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 ℃i-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.
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