Validação da determinação do teor de carbonato de cálcio em cápsulas por titulação complexométrica

Abstract

Calcium plays a range of important physiological functions in the human body, besides being one of the constituents of bone structure. People with deficiency of this mineral need supplementation to avoid diseases caused by low levels of it in the body. Four forms of calcium carbonate supplements are available at the Farmácia Escola FFOE/UFC. Because they are products intended for human consumption, quality and safety standards must be guaranteed by strict quality control. In this context, the present work should aim to validate the determination of calcium carbonate content in capsules by complexmetric titration for Laboratório de Controle de Qualidade Físico-Químico. The elaboration of this work had an experimental stage and later the statistical analysis of the data and interpretation. For the validation of the method, it was followed by the standards established by ANVISA through RDC 166/17. Selectivity showed no significant differences between the samples. Linearity obtained a high linear correlation (r = 0.9999). The accuracy presented DPR ranging from 0.41% to 1.12% between the analytical gears. The accuracy obtained recovery of the pattern between 97.91% and 98.54%. Robustness had a/a effect results (0.57 and 0.29) lower than the reference value (2.06 and 2.30). The calcium carbonate samples analyzed presented levels ranging from 94.48% to 107.49%. After evaluating all parameters, the results obtained showed that the methodology follows all requirements and, therefore, is suitable for use in determinations. After validation, the samples of calcium carbonate in capsules were evaluated by the method, both of which showed to be in compliance with the quality standards defined by the Farmacopeia brasileira. Finally, both the methodology in question and the samples analyzed by it presented results that demonstrated that they were within the standards required by the current regulations.