高效液相色谱法测定牛磺酸中主药及有关物质的含量

目的:建立测定牛磺酸中主药及有关物质含量的方法,并与《中国药典》(药典)方法和《美国药典》(USP)方法比较。方法:色谱柱为C18,柱前衍生化试剂为2,4-二硝基氟苯,流动相为乙腈-水-磷酸盐缓冲液(pH=7.0,20∶10∶70),检测波长为360nm,以峰面积外标法计算。结果:牛磺酸进样量在1.0μg~3.0μg范围内线性关系良好(r=0.9 999),平均回收率为99.80%(RSD=0.21%),衍生物在24h内稳定性良好(RSD=0.61%),最低检出量为0.02ng,比较得出本法与药典法和USP法测定的含量结果基本一致。结论:本方法简便、快速,灵敏度高,重现性好,结果准确、可靠。

Determination of Main Constituent and Relative Substance in Taurine by HPLC

OBJECTIVE: To establish a method for the determination of taurine,and to compare which with that stated in Chinese Pharmacopoeia(CP) and that stated in United States Pharmacopoeia(USP).METHODS: The separation was performed on a C18 column,with 2,4-dinitrofluorobenzen as precolumn derivatizing reagent,the mobile phase was composed of acetonitrile-water -phosphate buffer(pH=7.0)(20∶ 10∶ 70),the detection wavelength was set at 360nm,the computation was performed with peak area external reference method.RESULTS: The linear range of taurine was 1.0μ g～ 3.0μ g (r=0.9 999),and the recovery rate was 99.80%(RSD=0.21%),the derivative was stable within 24 hours(RSD=0.61%),the limit of detection was 0.02ng.Through comparison,this method was found to be basically in line with those adopted in CP and USP in determination results.CONCLUSION: The method is simple,rapid,sensitive,reproducible,accurate and reliable.