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目的建立HPLC法测定康肤霜制剂中醋酸氯己定的含量方法。方法采用C8柱(150 mm×4.6 mm,5μm)色谱柱,以1%三乙胺-甲醇-冰醋酸(50∶75∶0.4)为流动相,流速为1.0 ml·min-1,检测波长为259 nm。结果醋酸氯己定在5.02~35.14μg·ml-1(r=0.9999)范围内浓度与峰面积呈良好的线性关系;平均回收率为100.64%,RSD为0.74%(n=6)。结论本方法简便易行,快速、准确,可作为该制剂的质量控制方法。
OBJECTIVE To establish a HPLC method for the determination of chlorhexidine acetate in Kangshuang preparations. Methods The column with C8 column (150 mm × 4.6 mm, 5 μm) was used with mobile phase of 1% triethylamine-methanol-acetic acid (50:75:0.4) as the mobile phase at a flow rate of 1.0 ml · min- 259 nm. Results The concentration of chlorhexidine acetate in the range of 5.02 ~ 35.14μg · ml-1 (r = 0.9999) showed a good linear relationship with the peak area. The average recovery was 100.64% with a RSD of 0.74% (n = 6). Conclusion This method is simple, rapid and accurate and can be used as a quality control method for this preparation.