Resumen

TRIGO ORSINI, Myriam Lina  y  ABAN ARAMAYO, Elba Amalia. Validation of the analytical method by liquid chromatography of high resolution for the quantification of preservatives in orange juice  . Rev.Cs.Farm. y Bioq [online]. 2020, vol.8, n.2, pp.63-76. ISSN 2310-0265.

Abstract Introduction: Validation is the establishment of documentary evidence that an analytical procedure will lead, with a high degree of security, to obtaining precise and exact results within the specifications and previously established quality attributes. Objective: Validate the analytical method by High Resolution Liquid Chromatography for the quantification of preservatives in orange juice. Methods: The method was validated following the parameters referred to in USP 40 - NF 35, they are Specificity, Linearity, Precision (Instrumental Repeatability, Repeatability of the Method and Intermediate Precision) and Accuracy. Results: The proposed analytical method is Selective / Specific, it presents an excellent linearity within the range of 100 to 1000 ppm, the Precision presented results of CV <2% being optimal. The recovery is between 97 to 102% showing excellent accuracy. Conclusion: All the parameters and validation criteria were met, therefore the method is specific, selective, linear in the concentration range of 100 to 1000 ppm, sensitive, precise, reproducible and exact.

Palabras clave : Validation; High Resolution Liquid Chromatography; preservatives; orange juice.

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