HPLC法测定复方制剂中醋酸氯己啶的含量

Determination of chlorhexidine acetate in pharmaceutical products using high performance liquid chromatography

目的 介绍一种在复方制剂中测定醋酸氯己啶含量的高效液相色谱法。方法 采用C1 8柱和含十二烷基磺酸钠的甲醇 /水流动相的高效液相色谱法。结果 可获得优良的分离效果 ,对制剂中的醋酸氯己啶有高度性专一性 ,定量范围宽 (1 0～76 9mg·L-1 ) ,回收率良好 (99 83%～ 1 0 0 31 % ) ,分析精度高 (cev 0 1 5 % ) ,最低检测量 (0 1mg·L-1 )。结论 此法可有效地用于产品质量控制 。

AIM A high performance liquid chromatographic assay was developed to determine chlorohexidine acetate concentration in pharmaceutical products. METHODS Chromatographic separation was achieved on a C 18 column using a mobile phase of methanol water, containing sodium dodecyl sulfate. RESULTS AND CONCLUSION The method showed high selectivity to chlorohexidine acetate in pharmaceutical matrix,quantitative rang(1 0～76 9 mg·L -1 ), recovery(99 83%～100 31%),analytical precision(CV within 0 15%) and limit of detection (0 1 mg·L -1 ), permitting the effective application to quality control and stability testing of pharmaceutical products.