高效液相色谱法测定注射用硫普罗宁中硫普罗宁含量

摘要

Objective To establish a HPLC method for the determination of tiopronin in Tiopronin Injection. Methods The analysis was performed on the Waters C18 column(l50 mm×4. 6 mm,5 μm),using the mobile phase of water (adjusting pH to 2.2 with phosphoric acid) - acetonitrile (90 : 10).The flow rate was 1.0 mL/min. The detection wavelength was 210 nrn. Results The linear range of tiopronin was 25.01-400.16 μg/mL( r = 0. 999 9).The average recovery rate was 100.01%, RSD 0. 55% ( n =9). Conclusion This method is simple, quick, accurate and can be used to determine tiopronin in Tiopronin Injection.%目的 建立测定注射用硫普罗宁中硫普罗宁含量的高效液相色谱法.方法 采用waters C18色谱柱(150 mm×4.6 mm,5μm),水(磷酸调节pH为2.2)-乙腈(90:10)为流动相,流速为1.0 mL/min,检测波长为210 nm.结果 硫普罗宁质量浓度在25.01 ～400.16 μg/mL的范围内与峰面积线性关系良好(r=0.999 9),平均回收率为100.01％,RSD为0.55％(n=9).结论 该方法简便、快速、准确,可用于测定注射用硫普罗宁中硫普罗宁的含量.