摘要
目的:建立高效液相色谱法测定硫普罗宁注射液中的有关物质。方法:采用C18柱,以水(磷酸调节pH值为2.2)-乙腈(90∶10)为流动相,检测波长为210 nm。结果:硫普罗宁与其降解产物在该色谱条件下能够有效分离,检测限为0.11μg.mL-1,重复性试验RSD为0.8%。结论:该方法简便、快速、灵敏、准确,可用于测定硫普罗宁注射液中的有关物质。
Objective： To establish an HPLC method for the determination of related substances in Tiopronin Injection. Methods： The analysis was performed on a Ciscolumn,using mobile phase consisted of water （adjusted to pH 2. 2 with phosphoric acid）- acetonitrile （ 90： 10）. The detection wavelength was 210 nm. Results： The limit of detection was 0. 11 μg·mL-1. The repeatability was good （RSD = 0. 8% ）. Conclusion： The method was simple, quick, sensitive and accurate. Related substances in Tiopronin Injection can bc determined by HPLC.
出处
《中国药品标准》
CAS
2011年第5期349-352,共4页
Drug Standards of China
