Abstract

TRIGO ORSINI, Myriam Lina  and  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.

Keywords : Validation; High Resolution Liquid Chromatography; preservatives; orange juice.

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