摘要
目的：建立注射用硫普罗宁有关物质的测定方法。方法采用高效液相色谱法。用十八烷基硅烷键合硅胶为填充剂，以0．1mol/L磷酸二氢钾溶液-乙腈（95：5）为流动相，流速为：1．0ml．min -1，检测波长为210nm，进样体积为20μl。结果实验结果表明，高效液相法检测主峰与杂质峰有较好的分离度，且重复性，线性，专属性、强制降解前后的物质平衡、定量限均较好。结论该方法操作简便，结果可靠，适用于注射用硫普罗宁有关物质的检验。
Abstract
Objective To establish a method for determination of tiopronin phase by high performance liquid injection related substance .Methods Using high per-formance liquid chromatography.With eighteen alkyl silane bonded silica as filler,0.1mol/L potassium dihydrogen phosphate solution acetonitrile (95:5) as mobile phase,flow rate was:1.0ml.min -1 ,detection wavelength is 210nm,the injection volume was 20 μL.Results The detection,peak and impurity peak HPLC method has better separation,and the repeatability,specificity,forced degradation of material balance,and limits of quantification were better.Conclusion The method is simple,reli-able,and applicable to the inspection of tiopronin injection related substance.
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