Development and Validation of a Dissolution Test for 6 mg Deflazacort TabletsReport as inadecuate




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Departamento de Farmacia, Facultad de Ciencias Químicas, Universidad Nacional de Córdoba. Ciudad Universitaria. 5000-Córdoba, Argentine





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Abstract The aim of this study was to develop and validate a dissolution test for the quality control of deflazacort DEF tablets, a drug mainly used for the prevention of organ transplantation rejection, labeled as containing 6 mg of active pharmaceutical ingredient API, using an RP-HPLC method. After testing sink conditions and stability at 37°C, DEF was found to be unstable, and decomposed as a function of the dissolution media. However, in water the decomposition was not significant enough to interfere with the determination of dissolution for DEF. The best conditions to carry out the dissolution test were paddle at 50 rpm, with 500 mL of deaerated water at 37°C. Under these conditions, the in vitro release profiles of 6 mg DEF tablets produced by two different laboratories, representing all approved products in the national market, shown to be dissimilar. A correlation between disintegration and in vitro dissolution was found for the two investigated formulations. The developed dissolution test was adequate for its purpose and can be applied for the quality control of 6 mg DEF tablets.

Keywords: Quality control; In vitro release; RP-HPLC Quality control; In vitro release; RP-HPLC





Author: Norma R. SPERANDEO * and Diego E. KASSUHA

Source: http://mdpi.com/



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