The effect of beta-carotene on the photostability of nisoldipine.

The effect of beta-carotene on the photostability of nisoldipine (NS) has been investigated. Light stability studies were carried out following the recommendations of the International Conference on Harmonization (ICH), version I, using a high-pressure mercury lamp, type HBO-50, equipped with the interference filter and Wood's filter to isolate 365 nm wavelength. The photodegradation process was assayed by means of UV spectrophotometry and the reversed phase High-Performance Liquid Chromatography (HPLC). The quantum yields of photodegradation of NS and NS in the presence of beta-carotene were determined using the Reinecke salt as a chemical actinometer. The methanol solutions of NS degraded following apparent first-order kinetics. The degradation rate constant decreased as beta-carotene concentration increased. To verify the photostabilising role of the dye, a Stern-Volmer plot was constructed. The results have proved that beta-carotene does not act as a photosensitiser.

Spectroscopic and HPLC studies of photodegradation of nilvadipine.

Photochemical decomposition of nilvadipine (NV), a derivative of 1,4-dihydropyridine (DHP), was studied. 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 mercury arc lamp, type HBO 200 (300-400 nm). The maximum absorption of radiation at 365 nm was achieved by applying the interference filter and Wood's filter. The assessment of NV photodegradation was made on the basis of the UV spectrophotometric and high-performance liquid chromatographic (HPLC) methods. Quantitatively, the process was described with the calculated rate constants of decomposition k, time of decomposition of 50% of the compound to 5, and time of decomposition of 10% of the compound t(0.1). The two methods applied allowed a determination of the kinetic parameters of NV photodegradation from the relationship ln c = f(t). Using the Reinecke salt as a chemical actinometer, apparent quantum yields of photodegradation were obtained; after extrapolation to the time of irradiation zero, these gave the actual quantum yield (phi = 7.3 10(-5)). The quantum yield of fluorescence at lambda(exc) = 375 nm was about 9.3 x 10(-4) The methods used for evaluation of NV photodegradation were subjected to validation, and results of the analytical methods were statistically assessed by Snedecor F and Student t tests. The former test revealed no statistically significant difference between the variances obtained by the HPLC and UV spectrophotometric methods. Also, verification of the zero hypothesis of the Student t test on equality of means of the results obtained gave no significant diferences between the two methods.