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首页> 外文期刊>American Journal of Analytical Chemistry >Rapid HPLC Method for Determination of Parachloroaniline in Chlorhexidine Antiseptic Agent in Mouthrinses, Ophthalmic and Skin Solution
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Rapid HPLC Method for Determination of Parachloroaniline in Chlorhexidine Antiseptic Agent in Mouthrinses, Ophthalmic and Skin Solution

机译：快速高效液相色谱法测定漱口水，眼药水和皮肤溶液中洗必泰防腐剂中的对氯苯胺

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摘要

We described a simple and rapid method to quantify simultaneously chlorhexidine (CHD) and its major metabolite, para Chloroaniline (pCA) by HPLC with UV detection without the additional need of mobile-phase amine modifiers or ion-pairing reagents, with good resolution between pCA and CHD, symmetry peak of the compound and short run time. HPLC-UV analyses were performed using a Dionex? Summit liquid chromatograph (Dionex Corp, Sunnyvale, CA, USA). Chromatographic separations were carried out on a Luna? 150 mm×3 mm i.d. column packed with 3 μm CN (cyano) particles (Phenomenex?), guarded by an on-line filter. Mobile phase consist of methanol:water with sodium chloride with 0.02% of formic acid (55:45). Wavelengths for pCA and for CHD are 238 and 255 nm respectively. Influence of methanol and of sodium chloride content in the eluant has been studied. Linearity of CHD is very good, from 0.5 up to 21.2 μg/l while linearity of pCA is in the range of 0.05 to 10 μg/l with correlation coefficients above 0.999. Resolution between the components is above 4, asymmetry is about 1.3 and 1.7 for pCA and CHD respectively and the run time is less than 5 minutes. This method has been applied to CHD solution of different medical devices. No interference has been reported, and the analysis of direct injection of solution, without any treatment is achieved in less than five minutes.In conclusion, we present a validated method for dosage of CHD and its major impurity pCA, known to be carcinogen, available into medical products or medicinal device for in-vitro diagnostic.
机译：我们描述了一种简单快速的方法，可通过高效液相色谱（HPLC）和紫外检测同时定量洗必泰（CHD）及其主要代谢物对氯苯胺（pCA），而无需流动相胺改性剂或离子对试剂，pCA之间具有良好的分离度CHD，化合物的对称峰和短运行时间。 HPLC-UV分析使用Dionex？ Summit液相色谱仪（Dionex Corp，美国加利福尼亚州桑尼维尔）。色谱分离是在Luna？上进行的。 150毫米×3毫米内径色谱柱装有3μm的CN（氰基）颗粒（Phenomenex？），并由在线过滤器保护。流动相包括甲醇：水，氯化钠和0.02％的甲酸（55:45）。 pCA和CHD的波长分别为238和255 nm。研究了洗脱液中甲醇和氯化钠含量的影响。 CHD的线性非常好，从0.5到21.2μg/ l，而pCA的线性在0.05至10μg/ l的范围内，相关系数大于0.999。组件之间的分辨率高于4，pCA和CHD的不对称性分别约为1.3和1.7，运行时间少于5分钟。该方法已应用于不同医疗设备的冠心病解决方案。尚无任何干扰的报道，并且在不到五分钟的时间内不进行任何处理即可直接分析溶液的直接进样。总之，我们提供了一种经验证的冠心病及其主要杂质pCA（称为致癌物）剂量的验证方法。进入医疗产品或用于体外诊断的医疗设备。

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