注射用左旋泮托拉唑钠和泮托拉唑钠在氯化钠注射液中的稳定性研究

摘要

目的：以HPLC法对注射用左旋泮托拉唑钠和泮托拉唑钠在氯化钠注射液中的稳定性进行研究。方法：色谱柱：Chiral Pak IC柱（4.6 mm×150 mm，5μm）；流动相：10 mmol·L-1乙酸铵（含0.05%乙酸）-乙腈（35∶65）；流速：0.6 mL·min-1；检测波长：288 nm；柱温：30℃；进样体积：1μL。结果：注射用左旋泮托拉唑钠在氯化钠注射液中未发生左旋及右旋泮托拉唑间的手性转换；注射用左旋泮托拉唑钠和泮托拉唑钠在室内放置12 h稳定性良好，但在日光下放置后含量下降。结论：临床上使用注射用左旋泮托拉唑钠和泮托拉唑钠溶于氯化钠注射液时，须避免户外日光直射。%Objective: To establish an HPLC method to study the stability of S-pantoprazole sodium for injection and pantoprazole sodium for injection in normal saline solution. Methods: The chiral chromato-graphic separation was carried out on an Chiral Pak IC column (4.6 mm×150 mm, 5μm). The mobile phase consisted of 10 mmol·L-1 ammonium acetate solution (with 0.05% acetate)-acetonitrile (v/v, 35∶65) at a flow rate of 0.6 mL·min-1. The column temperature was 30℃, and the UV detection wavelength was 288 nm. The injection volume was 1μL. Results: Chiral inversion of S-pantoprazole was not appeared and S-pantoprazole sodium for injection and pantoprazole sodium for injection in normal saline solution were stable for 12 h at room temperature. The concentrations of S-pantoprazole sodium for injection and pantoprazole sodium for in-jection decreased when the solutions were exposed to direct sunlight. Conclusion: S-pantoprazole sodium for injection and pantoprazole sodium for injection in normal saline solution should be protected from sunlight.