HPLC法同时测定克敏乳膏中3种成分的含量
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篇名: HPLC法同时测定克敏乳膏中3种成分的含量
TITLE:
摘要: 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WondaSil 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10 μl。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 4 μg(r=0.999 9)、0.169 9~0.807 0 μg(r=0.999 9)、0.326 5~1.550 9 μg(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。
ABSTRACT: OBJECTIVE: To establish a method for the contents determination of lidocaine hydrochloride, chlorpheniramine maleate and chloramphenicol in Kemin cream. METHODS: HPLC was performed on the column of WondaSil C18 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 chloramphenicol (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, stability 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 chloramphenicol in Kemin cream.
期刊: 2016年第27卷第33期
作者: 陈晓亮,汪旭
AUTHORS: CHEN Xiaoliang,WANG Xu
关键字: 克敏乳膏;高效液相色谱法;盐酸利多卡因;马来酸氯苯那敏;氯霉素;含量测定
KEYWORDS: Kemin cream; HPLC; Lidocaine hydrochloride; Chlorpheniramine maleate; Chloramphenicol; Content determination
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