A NEW APPROACH OF ANALYSIS TO EVALUATE THE QUALITY OF CAPTOPRIL TABLETS USING HPLC
J. F. R. PAIVA*1, C. C. LOPES1, R. S. C. LOPES1, A. L. M. ALBERT1
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1Universidade Federal do Rio de Janeiro, Instituto de Química
This work describes the analytical HPLC method for the quantification of captopril and its degradation product, the captopril disulfide in captopril tablet 25 mg. For the development of analytical method, a comparative study of sample solutions stability of commercial batches of captopril tablets in a variety of solvents was carried out within a period of 24 hours, in order to evaluate in that diluent the sample solutions would present better stability. The aim of this study was to investigate analytical alternatives so that is minimized the oxidative degradation of captopril during the time of analysis, compared with the method of analysis described in the Brazilian Pharmacopoeia 5th edition and U.S. Pharmacopeia (USP 36). In analytical terms proposed in the official compendium – Brazilian Pharmacopoeia 5th edition and U.S. Pharmacopoeia 36 – the analysis method for the determination of captopril, as for the quantification of its degradation product of both the disulfide of captopril demonstrated to be inadequate. In terms of stability of the solution within 24 hours which can be seen the analytical results, was observed a significant decreasing of captopril with a significant increasing of the amount of captopril disulfide in the tablets when samples were analyzed during the period time of analysis proposed. Then we tried to keep the methodology of HPLC analysis, because it is a fast, accurate and stable method, changing only the diluent employed in the dilution of samples and standards in order to find a solvent that promotes captopril stability in solution for a period of at least 24 hours. At the end of the study, it was found that the solvent methanol among the tested solvents it demonstrated a great stability of sample solutions of captopril tablets with different validity times.
Financial Support: FAPERJ and CNPq; Area: Chemistry.
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