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ACTA Pharmaceutica Sciencia
2010 , Vol 52 , Num 2
DEVELOPMENT AND VALIDATION OF A HPLC METHOD FOR THE DETERMINATION OF VORICONAZOLE AND ITS DEGRADATION PRODUCTS IN PHARMACEUTICAL FORMULATION
Methodology Manager, SIGMA Corp., Egypt
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Simple, sensitive and accurate stability indicating analytical method for voriconazole has been developed and validated by using RP-HPLC techniques and applying the proposed method in the assay of voriconazole tablets (Vfend®), since there is no official monograph. The procedure was developed and validated under acidic, basic, oxidative and photo-irradiated conditions. Chromatography was performed with mobile phase containing a mixture of acetonitrile and 0.05M disodium hydrogen phosphate buffer, pH5.5 (1:1, v/v) with flow rate of 1.0 ml per min., C18 column and UV detection at 255 nm. developed method satisfies the system suitability criteria, peak integrity, and resolution for the parent drug and its degradants. The method was validated for linearity (correlation coefficient = 0.9999), accuracy, robustness and precision. The proposed method was simple, highly sensitive, precise and accurate and the run time less than 15 minutes indicating that the method is useful for routine quality control analysis and stability testing. Voriconazole was determined to be more sensitive to the basic conditions, photodegradation is observed only under severe conditions of light exposure, oxidation may also appear.but it was stable in acidic medium.
Keywords :
ASSAY, STABILITY INDICATING METHOD, VORICONAZOLE, HPLC