Identification of photodegradation products of nilvadipine using GC-MS.

Nilvadipine (NV) photodegradation products have been analysed with gas chromatography-mass spectrometry (GC-MS). The photodegradation was carried out in the conditions recommended in the first version of the document issued by the International Conference on Harmonization (ICH), currently in force in the studies of photochemical stability of drugs and therapeutic substances. Methanol solutions of NV were irradiated with a high-pressure UV lamp - type HBO 200. The maximum intensity at the wavelength lambda = 365 nm was achieved by applying the interference filter and Wood's filter. Using the Reinecke salt as a chemical actinometer, apparent quantum yields of photodegradation were obtained, which after extrapolation to the zero time of irradiation gave the actual quantum yield ((phi = 7.58 x 10(-5). The structure of three nilvadipine photodegradation products was established, after mass spectra analysis of compounds registered during GC-MS carried out of irradiated nilvadipine solutions. The quantitative results of GC-MS analyses enabled to determination of the kinetic parameters of NV photodegradation, calculated from the dependence In c =f(t). Quantitatively the process was described with the calculated rate constant of decomposition (k), decomposition time of 50% of the compound (t0.5) and decomposition time of 10% of the compound (t0.1). The exposure of nilvadipine to UV light was found to lead to aromatization of the DHP ring and elimination of the HCN molecule.