Spectrofluorimetric methods of stability-indicating assay of certain drugs affecting the cardiovascular system |
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Authors: | B A Moussa M F Mohamed N F Youssef |
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Institution: | 1.Pharmaceutical hemistry Department, Faculty of Pharmacy,Cairo University,Cairo,Egypt;2.National Organization for Drug Control and Research (NODCAR),Cairo,Egypt |
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Abstract: | Two stability-indicating spectrofluorimetric methods have been developed for the determination of ezetimibe and olmesartan
medoxomil, drugs affecting the cardiovascular system, and validated in the presence of their degradation products. The first
method, for ezetimibe, is based on an oxidative coupling reaction of ezetimibe with 3-methylbenzothiazolin-2-one hydrazone
hydrochloride in the presence of cerium (IV) ammonium sulfate in an acidic medium. The quenching effect of ezetimibe on the
fluorescence of excess cerous ions is measured at the emission wavelength, λem, of 345 nm with the excitation wavelength, λex, of 296 nm. Factors affecting the reaction were carefully studied and optimized. The second method, for olmesartan medoxomil,
is based on measuring the native fluorescence intensity of olmesartan medoxomil in methanol at λem = 360 nm with λex = 286 nm. Regression plots revealed good linear relationships in the assay limits of 10–120 and 8–112 g/ml for ezetimibe
and olmesartan medoxomil, respectively. The validity of the methods was assessed according to the United States Pharmacopeya
guidelines. Statistical analysis of the results exposed good Student’s t-test and F-ratio values. The introduced methods were
successfully applied to the analysis of ezetimibe and olmesartan medoxomil in drug substances and drug products as well as
in the presence of their degradation products. |
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