HPLC法同时测定克敏乳膏中3种成分的含量

Simultaneous Determination of Three Ingredients in Kemin Cream by HPLC

目的：建立同时测定克敏乳膏中盐酸利多卡因、马来酸氯苯那敏和氯霉素含量的方法。方法：采用高效液相色谱法。色谱柱为Wonda Sil C18,流动相为甲醇-乙腈-0.1%磷酸（梯度洗脱）,流速为1.0 ml/min,检测波长为254 nm,柱温为25℃,进样量为10μl。结果：盐酸利多卡因、马来酸氯苯那敏和氯霉素的检测进样量线性范围分别为0.604 5-2.871 4μg（r=0.999 9）、0.169 9-0.807 0μg（r=0.999 9）、0.326 5-1.550 9μg（r=0.999 9）;定量限分别为3.17、1.50、2.33 ng,检测限分别为0.95、0.45、0.70 ng;精密度、稳定性、重复性试验的RSD〈2%;加样回收率分别为98.29%-100.10%（RSD=0.64%,n=9）、98.04%-100.70%（RSD=0.80%,n=9）、98.02%-99.81%（RSD=0.70%,n=9）。结论：该方法结果准确、精密度高,可用于同时测定克敏乳膏中盐酸利多卡因、马来酸氯苯那敏和氯霉素的含量。

OBJECTIVE： To establish a method for the contents determination of lidocaine hydrochloride, chlorpheniramine ma- leate and chloramphenicol in Kemin cream. METHODS： HPLC was performed on the column of WondaSil C,8 with mobile phase of methanol-acetonitrile-0.1% phosphoric acid （gradient elution） at a flow rate of 1.0 ml/min, detection wavelength was 254 nm, column temperature was 25 ℃ and injection volume was 10 μl. RESULTS： The linear range was 0.604 5-2.871 4 μg for lidocaine hydrochloride（r=0.999 9）, 0.169 9-0.807 0 μg for chlorpheniramine maleate（r=0.999 9） and 0.326 5-1.550 9 μg for chlorampheni- col （r= 0.999 9） ; limit of quantitation was 3.17, 1.50,2.33 ng, limit of detection was 0.95,0.45,0.70 ng; RSDs of precision, sta- bility and reproducibility tests were lower than 2% ; recoveries were 98.29%-100.10% （RSD=0.64%, n=9）, 98.04%-100.70% （RSD=0.80%, n=9） and 98.02%-99.81% （RSD=0.70%, n=9）, respectively. CONCLUSIONS： The method is accurate with high precision, and can be used for the simultaneous determination of lidocaine hydrochloride, chlorpheniramine maleate and chlor- amphenicol in Kemin cream.