高效液相色谱法测定脂质体制剂中醋酸氯己定的含量

HPLC determination of the content of chlorhexidine acetate liposome

目的:探讨高效液相色谱法测定脂质体制剂中醋酸氯己定的含量的可行性。方法:以 Thermo Hypersil-Key Stone BDS C_(18)(4.6mm×250mm,5μm)柱为分离柱,流动相为甲醇-水(70:30,内含0.8mg·mL^(-1)的4-磺酸甲苯,用磷酸调 pH 2.5),检测波长为254nm,流速为1.0mL·min^(-1),柱温35℃,进样量10μL,按外标法测量峰面积。结果:醋酸氯己定在浓度10～100μg·mL^(-1)范围内与峰面积有良好的线性关系(r=0.9991)。醋酸氯己定的平均回收率97.48%。结论:方法简单、迅速、准确。

Objective ：To establish an HPLC method for the determination of chlorhexidine acetate in the liposome. Methods：The separation was performed on Thermo Hypersil -Key Stone BDS C18 （4. 6 mm ×250 mm,5 μm）. The mobile phase was composed of methanol -water（70： 30, containing 0. 8 mg · mL^ -1 toluene -4 -sulfonic acid monohydrate, adjusted to pH 2. 5 with phosphoric acid）. The detection wavelength was 254 nm, the flow rate was 1.0 mL^-1 ·min^-1 ,column temperature was 35 ℃ ,injection volume was 10 μL. Results：The calibration curves were linear between 10-100 μg· mL^-1 （r =0. 9991 ）. The average recoveries of chlorhexidine acetate was 97.48%. Conclusion： This method is simple, rapid and accurate. It is suitable for the determination of chlorhexidine acetate in the liposome.