Photodegradation of inclusion complexes of isradipine with methyl-beta-cyclodextrin.
The paper presents results of the studies on photochemical decomposition of isradipine (IS) and its liquid inclusion complexes with methyl-beta-cyclodextrin (M-betaCD). The process of photodegradation was assessed by the methods of UV spectrophotometry, HPLC (reverse-phase) and HPTLC (normal phase) chromatographic methods. The process of photodegradation of IS was analysed in the conditions of version I of the document of International Chemical Harmonization (ICH)-HBO-200 lamp. Quantitative evaluation of the photochemical decomposition was performed on the basis of the calculated photodegradation rate constant (k), half-life period (t0.5) and time of degradation of 10% of the compound (t0.1). Formation of inclusion complexes of IS with M-betaCD was proved to increase twice the photostability of the drug. The analytical methods used were subjected to a validation procedure in which the limits of detectability and determinability as well as specificity, precision and sensitivity of the method were determined.
Mielcarek
J
J
Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Karol Marcinkowski University of Medical Sciences, Poznań, Poland. bugajjol@main.amu.edu.pl
Daczkowska
E
E
D002121:Calcium Channel Blockers / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003505:Cyclodextrins / Q000737:chemistry*; D004355:Drug Stability; D017275:Isradipine / Q000737:chemistry*; D010777:Photochemistry; D015203:Reproducibility of Results; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D047392:beta-Cyclodextrins
D002121:Calcium Channel Blockers; D003505:Cyclodextrins; D047392:beta-Cyclodextrins; C108732:methyl-beta-cyclodextrin; D017275:Isradipine