Degradation Studies of Lacidipine: Identification, Isolation and Structural Characterization of Stress Degradation Products using LCMS, Mass mediated Prep-HPLC, NMR and HRMS

The stability of lacidipine drug under stress conditions and the identification of the degradation products, according to ICH guidelines Q1A (R2) were investigated in the hydrolytic and oxidative stress conditions. The drug degradation occurred under hydrolytic conditions like (acidic and basic) while it was stable in the oxidative condition. Three degradation products were formed under acidic condition and one degradation product was formed under basic condition, which was separated by using APMS (Auto Purification Mass Spectrometer) and gradient elution with C18 column. The four degradants have not been characterized earlier and in the present study all the structures were established and characterized using NMR spectroscopy (1D and 2D) and HRMS (high resolution mass spectrometer).