Abstract
A simple, stability-indicating, and compatible method by liquid chromatography with ultraviolet (LC-UV) and mass spectrometry (LC-MS) detections was developed for the evaluation of delapril (DEL) and manidipine (MAN) degradation products formed under alkaline and photolytic forced conditions, respectively. The chromatographic separation of all compounds was obtained within 7 min and carried out on a C18 column with mobile-phase composed by ammonium acetate and acetonitrile for both techniques. Thereby, the main degradation products detected were studied by LC coupled to electrospray ionization mass spectrometry (LC-ESI-MS). Based on retention times and molecular weight confirmation, a comprehensive degradation pathway for both drugs and the identity of its major products formed could be suggested, without complicated isolation or purification processes. The degradation kinetics of the drugs was also evaluated and could be best described as first-order process for DEL (R2 = 0.9991) and zero-order process for MAN (R2 = 0.9867). Furthermore, no evidence of cytotoxicity in human mononuclear cells was observed for DEL and MAN degraded samples. The proposed LC-UV method was successfully validated according ICH guidelines and thus helping to improve the quality control of pharmaceuticals.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
