高效液相色谱法测定施美乐涂膜中醋酸氯己定含量

摘要

Objective To establish a HPLC method for the determination of chlorhexidine acetate content in Shimeile Coating Film. Methods The analytic column:ODS C18(250 mm × 4. 6 mm;5 μm);the mobile phase:water (triethylamine 5mL and sodium dihy-drogen phosphate 7.8 g, adding water 450 mL, adjusting pH to 2.5 with 85% phosphoric acid,and then adding water to 500 mL) -methanol-acetonitrile(40 : 40 : 20); the detective wavelength was at 258 nm. Results The sample size of chlorhexidine acetate within the range of 0.212-1.060 μg showed a good linear relation with the peak area, r= 0.999 9. The average recovery rate was 100. 28% , RSD 1. 74%. Conclusion This method is simple to operate,good in reproducibility.and reliable and accurate in the detection results, which can be used for the quality control of this preparation.%目的 建立测定施美乐涂膜中醋酸氯己定含量的高效液相色谱法.方法 采用ODS C18柱(250 mm×4.6mm,5μm),以水相(取三乙胺5 mL,磷酸二氢钠7.8g,加水450 mL,用85％磷酸调pH至2.5,再加水至500 mL)-甲醇-乙腈(40∶40∶20)流动相,检测波长为258 nm.结果 醋酸氯己定进样量在0.212～1.060μg范围内与峰面积呈良好线性关系(r =0.999 9),平均回收率为100.28％,RSD为1.74％(n=6).结论 该方法操作简便,重现性好,结果准确可靠,适用于该制剂的质量控制.