Validación del Método Analítico para valoración de Vitamina A acetato por Cromatografía Líquida de alta eficiencia (HPLC) del producto farmacéutico Retinol 50000 UI comprimidos de la empresa Ginsberg S.A.

Abstract

The objective of the present investigation is to validate the analytical method used for the evaluation of Vitamin A acetate by high performance liquid chromatography (HPLC) of the pharmaceutical product Retinol 50000 UI tablets of the company GINSBERG S.A. Of the city of Quito, with the purpose of guaranteeing the quality and safety of the medication to the patient, through the identification, quantification of the active principle, guaranteeing that it is in the adequate dose so that it fulfills its therapeutic goal. Therefore, international organisms propose to analyze the following validation parameters as: the linearity of the analytical method, obtaining a correlation coefficient of 0.9998 and a CV of 0.71% for the accuracy of the method, a CV of 0.32% was obtained. As for the range determined for the validation were at concentrations of 60 and 140% achieving a CV of 0.55% and 0.99% respectively. Each of these results is found below the acceptance criteria which is <2%. Regarding the precision of the method analyzed through the repeatability, a CV of 0.11% and a recovery rate of 98% was obtained. For reproducibility between analysts, a 99.07% recovery with a CV of 0.67% was obtained Of the allowed range of 90-125% and CV <2%. The results obtained for the stability, after the samples had passed to 4 hours at room temperature, obtained a percentage of recovery of 89% and a CV of 0.11%, being within 85-95% and below 2%, that Are the permitted reference values. With regard to specificity, the method shows no interference with placebo, mobile phase and solvent. And the detection limit was determined to be 0.152 μg / ml, which means that under the established operating conditions; The validated analytical method shall detect and quantify such values. In conclusion the analytical method meets the acceptance criteria of the validation parameters, so it is considered validated and its application is recommended to guarantee the safety and quality of the pharmaceutical products.