高效液相色谱法测定盐酸川芎嗪注射液的含量

Determination of ligustrazine hydrochloride injection with HPLC

目的:建立高效液相色谱法测定盐酸川芎嗪注射液中盐酸川芎嗪含量的方法。方法:采用反相高效液相色谱法,使用Hypersil-C18(150 mm×4.6 mm,5μm)色谱柱,以甲醇∶水∶三乙胺(60∶40∶0.2醋酸调pH=5.80)作为流动相。流速1.0 ml/min,检测波长280 nm。结果:盐酸川芎嗪在20.0 mg/L^100 mg/L范围内线性较好,其线性方程为A=19987 C+10(n=6、r=0.9999)。盐酸川芎嗪的平均回收率为100.1%,RSD=0.19%(n=9)。结论:该方法快速、简捷、可靠、准确度高、重复性好,可用于盐酸川芎嗪注射液的质量控制。

Objective： To establish an HPLC method for the Determination of ligustrazine hydrochloride in its injection.Methods： The HPLC was used at an Hypersil-C18 column（4.6 mm×150 mm,5 μm） as analytical column,methanol-water-triethyl amine（60∶40∶0.2）（adjusted to pH=5.80 with acetic acid） as mobile phase.The flow rate was 1.0 ml/min and the UV detection wavelength was 280 nm. Results： The linear range of Ligustrazine hydrochloride was in the range of 20.0～100 μg/ml,the linear regression equation was A=19987 C＋10（n=6、r=0.9999）.The average recoveries was 100.1% with RSD =0.19%（n=9）. Conclusion： The method is simple,reliable,accurate and can be used to the quality control of the injection.