Desloratadine analysis: as a pharmaceutical preparation and after accelerating ageing

Desloratadine is a biologically active compound that is not described in the Polish Pharmacopoeia IX, hence, its study is particular important. The aim of this work was to establish a procedure for desloratadine analysis by way of HPTLC in combination with densitometry, so as to be able to ascertain its presence and degree of presence within pharmaceutical preparations. In our work, a mixture of ethyl acetate, n-butanol, ammonia and methanol was used as the mobile phase. Moreover, HPTLC plates precoated with silica gel 60F₂₅₄ were also employed. The proposed method was tested and subsequently validated. Spectrodensitometric analysis was then performed to determine the optimal wavelength for the quantitative determination (λ=276 nm), and following this, a quantitative analysis of desloratadine within certain pharmaceutical preparations was performed. Our research also took into consideration an analysis of the products of desloratadine decomposition that come about as a result of the accelerated aging of its solutions. The employed procedure for accelerating the aging of such desloratadine solutions consisted of heating these at 40℃ and then irradiating the solution surfaces with UV light. The changing color of these solutions after 2 hours of exposure served to indicate that degradation had occurred. Of note: as a result of irradiation with UV light, desloratadine content was seen to decrease with time, declining to almost zero after 30 hours. However, heating a solution of desloratadine alone did not induce a change in its content. Solutions of desloratadine that had previously undergone irradiation and heating were also analyzed to ascertain whether new substances were present. For this purpose, the GC-MS process was employed. As a result of this procedure, the spectrum of the solution after aging showed the presence of several new peaks that displayed retention several times larger and smaller than the normal desloratadine peak.