Validación de un método analítico por cromatografía liquida de alta eficiencia para la cuantificación del principio activo en un producto terminado
...
Claros Peña, Johan Sebastián | 2018
The objective of this work is to develop a validation of analytical method by HPLC High Efficiency Liquid Chromatography, in the quantification of the folic active ingredient, in the finished product, in compliance with the standards established by USP40, NTC 17025 and BPL and the renewal of the registration for the INVIMA.
Following those parameters, the Liquid Chromatography High Efficiency (HPLC), an analytical technique, was carried out to quantify the folic acid in a finished good. That product was supplied from the MERCK Subsidiary to ALTEA FARMACEUTICA, which is composed as follows; calcium citrate tetra hydrated 950.0mg, vitamin D3 dry type 100 SD/S 4.0mg, ferrous fumarate 54.762mg and folic acid 0.4mg and it is called "Finished product" in this research because of data protection. The mobile phase consisted of buffer solution of 0.05M potassium phosphate, acetonitrile (960:40), pH 6.5. Samples were prepared in triplicate to ensure the chromatographic method’s reproducibility. And these were punctually evaluated by the following validation parameters, linearity, accuracy, system precision, and uniformity content, to obtain the asset´s recovery percentage of 99.88%.
LEER
