HPLC法测定盐酸氯己定的有关物质和含量

Determination of Chlorhexidine Hydrochloride and Its Related Substances by HPLC

目的:建立高效液相色谱法测定盐酸氯己定有关物质和含量的方法。方法:采用资生堂MG C18(250 mm×4.6 mm,5μm)色谱柱;以辛烷磺酸钠溶液(取辛烷磺酸钠2.0 g,加冰醋酸120 ml,水270 ml)-乙腈(60∶40)为流动相;流速:1.0 ml·min^(-1);检测波长:254 nm;柱温:35℃;进样量:20μl。结果:在此色谱条件下,盐酸氯己定和相邻杂质峰分离良好,盐酸氯己定在0.050.16 mg·ml^(-1)的质量浓度范围内线性关系良好(r=1.0000),平均加样回收率100.8%(RSD=0.6%,n=9),9批样品杂质总量均小于1.5%。结论:该方法简便、准确,可更好的控制盐酸氯己定的质量。

Objective:To establish an HPLC method for the determination of chlorhexidine hydrochloride and its related substances.Methods:The chromatorgraphic conditions adopted were as follows:a Shiseido C18(250 mm×4.6 mm,5μm)column was used,sodium octane sulfonate solution-acetonitrile(60∶40)was used as the mobile phase at the flow rate of 1.0 ml·min^(-1),the detection wavelength was at 254 nm,the column temperature was 35℃,and the injection volume was 20μl.Results:Under the above conditions,the main peak and the peaks of related substances were separated quite well.Chlorhexidine hydrochloride had a good linear relationship within the range of 0.05-0.16 mg·ml^(-1)(r=1.0000).The average recovery was 100.8%(RSD=0.6%,n=9).The total impurity of 9 batches of samples was less than 1.5%.Conclusion:The method is simple and accurate,and can be used for the quality control of chlorhexidine hydrochloride.