GC法测定咳特灵胶囊中马来酸氯苯那敏含量

Determination of Chlorphenamine Maleate in Keteling Capsules by GC

目的建立GC法测定咳特灵胶囊中马来酸氯苯那敏含量的方法。方法采用SPB-5石英毛细管柱经程序升温技术分离待测组分,内标法计算含量。程序升温,初始温度190℃,保持2 min,以10℃每分的速度升温至290℃,保持3 min;进样口温度270℃;FID检测器;检测器温度300℃。结果检测灵敏度高,待测组分与内标物分离良好,马来酸氯苯那敏在0~0.6mg/m L（r=0.999 5）范围内呈良好线性关系,平均加样回收率为96.81%（RSD=0.54%,n=6）。结论该法简便快速,结果准确,可用于测定该药品的含量。

OBJECTIVE To establish a method for the determination of chlorphenamine maleate in Keteling capsules by GC.METHODS The samples were isolated by an SPB-5 silicon capillary column,and the results were detected by an internal standard method. The temperature was raised by temperature programming,with an original temperature at 190 ℃ kept for 2 min,raised to 290℃ at the rate of 10 ℃ / min and kept for 3 min. The injector temperature was at 270 ℃,and the FID detector temperature was at 300 ℃.RESULTS Good separation was obtained in the quantitative determination. The calibration curves showed good linear relationship within the range of 0-0. 6 mg / m L（ r = 0. 999 5） for chlorphenamine maleate. The average recovery of chlorphenamine maleate was96.81%（ RSD = 0.54%,n = 6）. CONCLUSION The method is convenient,rapid,accurate and suitable for the determination of the preparation.