盐酸法舒地尔注射液影响因素试验及其光降解产物的液相色谱-质谱分析

Influential Factors for Quality of Fasudil Hydrochloride Injection and Liquid Chromatography-Mass Spectrometry Analysis of Its Photodegradation Product

目的考察盐酸法舒地尔注射液的影响因素并鉴定其光降解产物。方法对盐酸法舒地尔注射液进行高温、光照处理,并用液相色谱-质谱联用技术鉴定其光降解产物。结果盐酸法舒地尔注射液高温条件下稳定,光照条件下产生一光降解杂质异喹啉-5-磺酸。结论盐酸法舒地尔注射液在高温条件下稳定,在光照条件下不稳定,应避光保存,光降解杂质为异喹啉-5-磺酸。

Objective To investigate the influencing factors for the quality of Fasudil Hydrochloride Injection and identify its photodegradation product. Methods Fasudil Hydrochloride Injection was put at high temperature and under illumination. The photodegradation product of Fasudil Hydrochloride Injection was identified by liquid chro- matography mass spectrometry. Results Fasudil Hydrochloride Injection was stable at high temperature, but pro- duced isoquinoline-5-sulfonic acid as an impurity under illumination. Conclusion Fasudil Hydrochloride Injection is stable at high temperature, but it is unstable under illumination, with isoquinoline-5-sulfonic acid as a photodegra- dation product. Fasudil Hydrochloride Injection should be kept in the dark.