高效液相色谱法测定醋酸氯己定痔疮栓的含量

Determination of Chlorhexidine Acetate Hemorrhoid Suppositories by HPLC

目的建立测定醋酸氯己定痔疮栓中酸酸氯己定含量的高效液相色谱(HPLC)法。方法色谱柱为C18柱(150mm×4.6mm,5μm),流动相为0.8%三乙胺(冰醋酸调pH至4.9)-甲醇(40:60),流速1.0mL/min,检测波长259nm。结果醋酸氯己定质量浓度在16～120μg/mL范围内与峰面积线性关系良好(r=0.9999,n=5),平均回收率为98.67%,RSD=1.36%(n=6)。结论所用方法简单、准确、重现性好,可用于醋酸氯己定痔疮栓的含量测定。

Objective To establish a HPLC method for the determination of chlorhexidine in Chlorhexiding Acetate Hemorrhoid Suppositories. Methods The C18 column was used. The mobile phase consisted of 0. 8% triethylamine（adjusted to pH 4.9 with acetic acid）-methanol （40：60）; the flow rate was 1.0mL/min; the detection wavelength was 259 rim. Results The linear range of chlorhexidine acetate was 16- 120 μg/mL（r=0.9999, n=5）.The average recovery rate was 98.67%,RSD=1.36%（n=6）.Conclusion The method is simple and accurate with good reproducibility, which is suitable for the content determination of Chlorhexiding Acetate Hemorrhoid Suppositories.