目的建立了HPLC测定硫普罗宁注射液的含量及有关物质。方法采用Waters Symmetry C₁₈柱(4.6mm×200mm,5μm);流动相:0.025mol·L^-1磷酸二氢钾溶液(用磷酸调pH值至3.2)-乙腈(95∶5);检测波长:210nm;柱温:30℃;流速:1.0mL·min^-1;进样量:20μL。结果硫普罗宁与杂质分离良好,在0.020～0.996g·L^-1内呈良好的线性关系,r=0.9998。平均回收率(n=9)为99.50%。结论该方法灵敏快速、结果准确、重现性好,可用于该制剂的质量控制。

OBJECTIVE To establish a HPLC method for the determination of tiopronin injection and its related substances. METHODS The separation was performed on a Waters Symmetry C₁₈ (4.6 mm×200 mm,5 μm) column. The mobile phase consisted of 0.1 mol·L^-1 potassium dihydrogen phosphate solution(adjust to pH 3.2 with glacial acetic acid)-acetonitrile (95∶5). The detective wavelength was 210 nm. The column temperature was 30 ℃. The flow rate was 1.0 mL·min^-1. The injection volume was 20 μL. RESULTS A good separation of tiopronin and main related substance was achieved. A good linearity was obtained over the range of 0.020～0.996 g·L^-1 (r=0.999 8). The average recovery (n=9) was 99.50%. CONCLUSION The method is simple, quick, sensitive, accurate, repeatable and can be used to control the quality of tiopronin injection.