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目的建立并优化测定美司钠注射液含量及有关物质的高效液相色谱方法。方法以磷酸盐缓冲液-甲醇(665∶335,V/V),用稀释的磷酸溶液调节pH值至(2.3±0.1)为流动相,检测波长235 nm,柱温30℃,流速为1.0 ml.min-1,采用优化的高效液相色谱法(HPLC)法测定美司钠注射液含量及有关物质。结果美司钠在浓度为1.07～10.58 g.L-1范围内有良好的线性关系,相关系数为0.999 6,平均加样回收率为100.4%,RSD为1.0%。结论该方法操作简单、快速、准确,可用于美司钠注射液中有关物质的检测和含量测定。
Objective To establish and optimize the HPLC method for the determination of the content and related substances of mesna injection. Methods The pH was adjusted to (2.3 ± 0.1) with phosphate buffer-methanol (665: 335, V / V) using dilute phosphoric acid solution as mobile phase at a detection wavelength of 235 nm with a column temperature of 30 ℃ and a flow rate of 1.0 ml min-1, and the contents of mesna injection and related substances were determined by the optimized high performance liquid chromatography (HPLC). Results There was a good linear relationship between the concentration of mesna and 1.07 ~ 10.58 g.L-1, the correlation coefficient was 0.999 6, the average recovery was 100.4% and the RSD was 1.0%. Conclusion The method is simple, rapid and accurate and can be used for the determination and determination of related substances in the injection of sodium.