Desenvolvimento e validação de método analítico para determinação de teor de ácido gálico e catequina no fitoterápico sanativo® por cromatografia líquida de alta eficiência

摘要

The herbal medicine Sanativo® is produced by the Pernambucano Laboratorysince 1888 with indications of healing and hemostasis. It is composed of a fluidextract about Piptadenia colubrina, Schinus terebinthifolius, Cereus peruvianus andPhysalis angulata. Among the plants in their composition, S. terebinthifolius and P.colubrina have in common phenolic compounds which are assigned most of itspharmacological effects. The tannins, gallic acid and catechin were selected asmarkers for quality control. The aim of this study was the development and validationof analytical method by HPLC/UV/DAD for the separation and simultaneousquantification of gallic acid (GAC) and catechin (CTQ) in Sanativo®. Thechromatographic system was to stationary phase, C-18 RP column, 4,6 x 150 mm (5mm) under a temperature of 35 ° C, detection at 270 and 210 nm. The mobile phaseconsisted of 0.05% trifluoroacetic acid and methanol in the proportions 88:12 (v/v), aflow rate of 1 ml/min. The analytical method presented a retention factor of 0.30 and1.36, tail factor of 1.8 and 1.63 for gallic acid and catechin, respectively, resolution of18.2, and theoretical plates above 2000. The method validation parameters met therequirements of Resolution n º 899 of May 29, 2003, ANVISA. The correlationcoefficient of linear regression analysis for GAC and CTQ from the standard solutionwas 0.9958 and 0.9973 and when performed from the Sanativo® 0.9973 and 0.9936,the matrix does not interfere in the range 70 to 110 %. The limits of detection andquantification for GAC and CQT were 3.25 and 0.863, and 9.57 and 2.55 mg/mL,respectively. The markers, GAC and CQT, showed repetibility (coefficient of variationof 0.94 % and 2.36 %) and satisfactory recovery (100.02 ± 1.11 % and 101.32 ± 1.36%). The method has been characterized selective and robust quantification of GACand CTQ in the Sanativo® and was considered validated