HPLC法测定复方制剂中的醋酸洗必泰的含量

Determination of Chlorhexidine Acetate by HPLC

目的 建立高效液相色谱法测定醋酸洗必泰的含量的方法。 方法 采用 Agilent C18色谱柱 (5 μm,4 .6 mm×15 0 mm) ,以甲醇 :0 .1mol/L Na H2 PO4 (6 8:32 ,用 H3PO4 调节 p H值至 3)为流动相 ,流速 1.0 m L/min,波长 2 5 9nm,柱温为 2 5℃ ,进样体积为 5 μL。 结果 线性范围 :0～ 10 0 0 ng,r=0 .99998(n=8)。加标回收率 85 .6 %～ 10 4 .0 %。最低检测限 (S/N=3∶ 1)为 0 .5 ng。最低定量限 (S/N=10∶ 1)为 1.6 5 ng。 结论 本法简便快速 ,定量准确 ,灵敏度高 ,重现性好 ,适用于不同复方制剂中的醋酸洗必泰的测定 。

Objective To establish a HPLC method for the determination of Chlorhexidine Acetate. Methods The HPLC system consisted of Agilent C18 column(5μm, 4.6 mm×150 mm), and mobile phase was composed of methanol:0.1 mol/L potassium dihydrogen phosphate(68 : 32, adjust pH to 3 by phosphoric acid). The flow rate was 1.0 mL/min, detection wavelength was at 259 nm, column temperature was at 25℃, the injection volume was 5μL. Result The calibration curves was linear in the range of 0~1000ng for Chlorhexidine Acetate (r= 0.99998, n = 8). The recoveries of Chlorhexidine Acetate is 85.6~104.0%. The detection limit (S/N = 3∶1) was 0.5 ng of Chlorhexidine Acetate. Conclusion This method is simple, rapid and accurate, high sensistive and with good reproducibility, and suitable for the determination of Chlorhexidine Acetate in componds. It can be used for the quality control of products.