Resumen

TRAVIESO NOVELLES, María del Carmen et al. Validation of the total tannin quantitative determination method in Rhizophora mangle L. (red mangrove) semi-solid formulations. Rev Cubana Plant Med [online]. 2011, vol.16, n.1, pp.82-93. ISSN 1028-4796.

Introduction: Rhizophora mangle L. (red mangrove) aqueous extracts have high tannin content that gives them antiseptic and healing features. Objective: to demonstrate the validity of total tannin quantitative determination method for the quality control of semi-solid red mangrove formulations. Methods: The linearity, precision, accuracy, selectivity and robustness indicators were studied in pursuant to the USP guidelines and the Regulation 41 of CECMED for the quantitative determination methods of the content or purity of majority active principles. Results: the linearity in the 0.40-1 mg/mL range of the used pattern was proved, the equation of the straight line with determination and correlation (r² y r) coefficients equal to 0.9912 and 0.9956 respectively were obtained, and the intercept and the slope did not differ from 0 and 1, respectively. The recovery studies showed recovery rates over 98 % at the various levels of concentration tested, which indicated adequate accuracy. The method was precise both in optimal repeatability conditions and intermediate conditions. The selectivity results revealed that the method response did not interfere with other components of the formulation, and that there was no response in the placebos. Robustness was confirmed since no significant differences between the results from the normal test runs and from the test runs including changes (temperature and centrifugation time, slight variations in the buffer pH) were observed, being all these results not significant. Conclusions: the total tannin quantitative determination method was reliable for the evaluation of these compounds in the studied semi-solid formulation.

Palabras clave : Rhizophora mangle L; validation; semi-solid formulations; total tannins.

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