高效液相色谱法测定盐酸乙哌立松中的有机杂质

Determination of organic impurities in eperisone hydrochloride by HPLC

目的建立高效液相色谱法测定盐酸乙哌立松中的有机杂质。方法采用CAPCELL pak C18MGⅡS5(4.6 mm×150 mm,5.0μm)色谱柱,柱温:30℃;流速:1.0 mL·min^-1;流动相:磷酸盐缓冲液(pH 7.5)-乙腈=40∶60;检测波长:254 nm,进样量:10μL。结果对于盐酸乙哌立松中的6个特定杂质,杂质A、B、C、D、E、F的线性范围分别为:0.030~2.26、0.013~2.25、0.017~2.25、0.048~2.15、0.017~2.14、0.027~2.26μg·m L^-1。杂质A、B、C、D、E、F的检测限分别为0.008、0.003、0.005、0.015、0.005、0.008μg·mL^-1。结论该方法可用于盐酸乙哌立松中有机杂质的检测。

Objective To establish an HPLC method for the determination of organic impurities in eperisone hydrochloride. Methods CAPCELL pak C18 MGⅡ S5(4.6 mm×150 mm, 5.0 μm) was used. The column temperature was 30 ℃, the flow rate was 1.0 mL·min^-1, the mobile phase was PBS(adjusted to pH 7.5)-acetonitrile(40∶60), the detection wavelength was 254 nm, and the sampling injection was 10 μL. Results The linear ranges for impurity A, B, C, D, E, and F was 0.030-2.26, 0.013-2.25, 0.017-2.25, 0.048-2.15, 0.017-2.14, and 0.027-2.26 μg·m L^-1. The detection limits of impurity A, B, C, D, E, and F was 0.008, 0.003, 0.005, 0.015, 0.005, and 0.008 μg·mL^-1. Conclusion The method is suitable for determining the organic impurities in eperisone hydrochloride.