注射用右旋兰索拉唑和兰索拉唑在氯化钠注射液中的稳定性考察

摘要

Objective: To evaluate the stability of dex-lansoprazole injections and lansoprazole injections in the normal saline solutions. Methods: The separation of lansoprazoles was performed on an IC chiral column (4.6 mm×150 mm, 5μm). The mobile phase was 10 mmol·L-1 ammonium acetate solution (with 0.05% acetic acid)- acetonitrile (50∶50) at a flow rate of 0.6 mL·min-1. The column temperature was 30℃, and the UV detection was set at 284 nm. The injection volume was 1μL. Results and Conclusions: Chiral inversion was not observed and the labeled contents of dex-lansoprazole injections and lansoprazole injections in normal saline solutions were over 98% in 4 h at room temperature. The concentrations were lower when the solutions were exposed in solar radiation compared with those placed indoor.%目的：对注射用右旋兰索拉唑和兰索拉唑在氯化钠注射液中的稳定性进行考察。方法：建立HPLC-UV法，采用Chiral PAK IC手性柱（4.6 mm×150 mm，5μm）；流动相：10 mmol·L-1乙酸铵（含0.05%乙酸）-乙腈（50∶50）；流速：0.6 mL·min-1；检测波长：284 nm；柱温：30℃；进样量：1μL。结果与结论：在室温下，注射用右旋兰索拉唑在氯化钠注射液中不发生手性转换；注射用右旋兰索拉唑和兰索拉唑在室内放置4 h标示含量>98%，暴露于日光下则发生明显的含量下降。