Validation of an analytical method by HPLC applicable to the cuban Mangiferin

Purpose: The purpose of this study was to validate, in accordance with international standards, a chromatographic method to determine the mangiferin in Cuban's samples, obtained from Mangifera indica leaves. Materials and Methods: A GraceSmart RP -18 (150 mm x 4,6 mm i.d., 5 mu m particle size) column and mobile phase of potassium dihydrogen orthophosphate (0.01 M) pH 2.7 +/- 0.2 - acetonitrile (85:15, v/v) with the flow rate of 1,0 mL/min and UV detection at 254 nm wavelength is used. The validated method was compared with the established method for the quality control of the Cuban's mangiferin samples, through the Student test. In the validation study the parameters were evaluated: specificity, precision (repeatability, intermediate precision and reproducibility), accuracy, linearity, robustness and detection and quantification limits. Results and Discussion: It was demonstrated that the developed procedure, was the sufficiently lineal thing, with a detection limit of 10 % and 30 % like quantification limit, specific, precise, exact and robust for the determination of mangiferin content in the Cuban's samples. The results obtained from the validation process provided documentary evidence of the reliability of the chromatographic method; In addition, no significant differences were observed between the chromatographic methods evaluated, so that the validated method can be applied in the quality control of the Cuban's samples. Conclusions: The method used in the quantification of mangiferin was was specific, lineal, precise, exact and robust, for quality control and stability study.

Jaar van publicatie:2018