Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

Direct spectrofluorimetric methods as alternatives to compendial ones used for the quality control of biopharmaceuticals: development, validation and application

A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and ther...

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Bibliographic Details
Published in:Brazilian Journal of Pharmaceutical Sciences Vol. 60
Main Authors: Souza, Thallis Martins, Angelino, Robert da Silva, Ornella, Larissa Manhães, Ribeiro, Eduardo dos Santos, Fernandes, Simone Ferreira Rodrigues
Format: Journal Article
Language:English
Published: Sao Paulo Universidade de Sao Paulo Faculdade de Ciencias 01-01-2024
Universidade de São Paulo, Faculdade de Ciências Farmacêuticas
Universidade de São Paulo
Subjects:
4-aminobenzoic acid
Amino acids
Analytical validation
Aromatic amino acids
Fluorescence spectroscopy
Laboratories
Methods
Nanoparticles
Pharmaceuticals
PHARMACOLOGY & PHARMACY
Proteins
Quality control
Raw material
Raw materials
Spectrum analysis
Streptococcus infections
Vaccines
United States > US
Switzerland
Germany
Fluorescence spectroscopy
Aromatic amino acids
4-aminobenzoic acid
Analytical validation
Raw material
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Description
Summary:A simple, rapid, precise, accurate and sustainable spectrofluorimetric method (SFM) was developed, validated and applied for the determination of 4-aminobenzoic acid and aromatic amino acids (phenylalanine, tryptophan and tyrosine). These compounds are used in biopharmaceutical formulations and therefore must be analyzed by quality control laboratories to meet the criteria established in pharmacopoeias. In general, potentiometric titration (PT) is described in the compendia as the official analytical technique. However, this method showed low sensitivity and selectivity, and moreover was performed with a non-aqueous solvent (acetic acid), which led to higher consumption of reagents and consequently to the formation of residues. Therefore, the SFM was developed in aqueous medium at pH 7.2 using phosphate buffer. It was successfully validated according to the ICH guidelines and showed good linearity range (r>0.999), specificity, accuracy and precision (within and between days) and robustness. The test results were compared between the SFM and PT using raw material samples, while according to the F- and t-tests at 95% confidence level, no statistical difference was found between the methods.
ISSN:2175-9790
1984-8250
2175-9790
DOI:10.1590/s2175-97902024e23126