高效液相色谱法测定硫酸氢氯吡格雷的含量

摘要

Objective: To establish a method for determination the content of Clopidogrel hydrogen sulfate. Methods: Sino Chrom ODS-BP column (4.6 mm×200 mm , 5 μ m) was used , mobile phase was 1％ triethylamine (pH=4.0)-acetontrile (25:75) ,detection wavelength was 225 nm. Results: Clopidogrel hydrogen sulfate sample size located 0.48-0.72μg, and favourable linear correlation (r=0.999 9) was showed. The flow rate was 1.0 ml/min. Conclusion: The method is convenient and accurate. Meanwhile, it also has good reproducibility, may he used to quality control of Clopidogrel hydrogen sulfate.%目的:建立硫酸氢氯吡格雷的含量测定方法.方法:采用HPLC法,色谱柱Sino Chrom ODS-BP(4.6 mm×200 mm,5μm),流动相:1%三乙胺(pH=4.0)-乙腈(25:75),检测波长:225 nm,流速:1.0 ml/min.结果:硫酸氢氯吡格雷进样量在0.48～0.72 μg范围内呈良好的线性关系(r=0.999 9).结论:本法简便、准确,重复性好,可用于该产品的质量控制.