HPLC法测定注射用亚锡二巯丁二钠中二巯丁二酸的含量

摘要

目的：以四丁基碘化胺为离子对试剂，采用离子对反相高效液相色谱法测定注射用亚锡二巯丁二钠中二巯丁二钠的含量。方法：采用SunFireTM C18色谱柱，流动相为6.5 g·L-1磷酸二氢钠溶液∶甲醇=（80∶20），流速1.0 mL·min-1，检测波长220 nm，柱温25℃。结果与结论：二巯丁二钠在1.92～17.28μg范围内线性良好（r=0.999）；平均加样回收率为98.8%，RSD为1.3%。本方法适用于注射用亚锡二巯丁二钠的质量控制。%Objective: To establish a reversed-phase HPLC method for determination of succimer in the kit of sodium succimer and stannous chloride mixture for injection. Methods: Tetrabutylammonium iodide was used as the ion pair reagent. A SunFireTM C18 ODS column was adopted with 6.5 g·L -1 sodium dihydrogen phosphate solution-methanol (80∶20) as the mobile phase at a flow rate of 1.0 mL·min-1, and the eluate was detected at 220 nm. ResuIts and ConcIusion: The curve was linear in the range of 1.92-17.28μg (r=0.999), the average recovery was 98.8% and RSD was 1.3%. This method can be used for the quality control of the active pharmaceutical ingredient.