HPLC同时测定利多卡因氯己定气雾剂中的3个有效成分

Simultaneous determination of lidocaine,chlorhexine acetate and benzalkonium bromide in Lidocaine and Chlorhexine acetate aerosol by HPLC

目的采用HPLC法同时测定利多卡因氯己定气雾剂中利多卡因、乙酸氯己定和苯扎溴铵的含量。方法采用Waters Sun Fire C18色谱柱（150 mm×4.6 mm,5μm）,以甲醇-2.4 mmol·L-1三氟乙酸溶液作流动相,梯度洗脱,流速1.0 m L·min-1,柱温35℃,检测波长218 nm。结果利多卡因、乙酸氯己定、苯扎溴铵的线性范围分别为0.12021.202 mg·m L-1（r=0.9999）、29.6295.8μg·m L-1（r=0.9998）、6.565.4μg·mL-1（r=0.9996）;平均回收率分别为100.79%、100.17%、100.00%,RSD分别为0.31%、1.12%、1.06%（n=6）。结论所用方法可同时测定利多卡因氯己定气雾剂中利多卡因、乙酸氯己定和苯扎溴铵的含量,适用于利多卡因氯己定气雾剂的质量控制。

OBJECTIVE To establish an HPLC method for the simultaneous determination of lidocaine,chlorhexine acetate and benzalkonium bromide in Lidocaine and Chlorhexine acetate aerosol. METHODS The separation was carried out on a Waters Sun Fire C18 column（150 mm × 4. 6 mm,5 μm）,the mobile phase was consisted of 2. 4 mmol·L-1 trifluoroacetic acid solution and methanol at a flow rate of 1. 0 m L·min-1,with the column temperature of 35 ℃. The detection wavelength was set at 218 nm. RESULTS The calibration curve was linear over the range of 0. 1202-1. 202 mg·m L（-1）（r = 0. 9999） for lidocaine,29. 6-295. 8 μg·m L（-1）（r =0. 9998） for chlorhexine acetate and 6. 5-65. 4 μg·m L（-1）（r = 0. 9996） for benzalkonium bromide. The average recovery of the three components were 100. 79%,100. 17%,100. 00% with the RSD of 0. 31%,1. 12%,1. 06%（ n = 6）,respectively. CONCLUSION This method can be used for simultaneous determination of lidocaine,chlorhexine acetate and benzalkonium bromide in Lidocaine and Chlorhexine acetate aerosol,and it is applicable for the quality control of Lidocaine and Chlorhexine acetate aerosol.