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Analytical Validation of an ATR-FTIR Based Method for Quantifying the Amount of Polysorbate 80 Adsorbed on the PLGA Nanoparticles

preprint
submitted on 31.07.2020 and posted on 04.08.2020 by Nabodita Sinha, Abhayraj Shrikrishna Joshi, Ashwani Thakur

Nanomedicine is envisioned to have a tremendous impact on targeted drug delivery in future. Coating of nanoparticles with non-ionic surfactants has been often employed for enhancing targeting in drug delivery systems. Polysorbate 80 is one of the non-ionic surfactants used often as a coating agent for receptor-mediated endocytosis into the brain. However, very few studies have been done to investigate the actual amount of the surfactant adsorbed or the mechanism of adsorption onto the nanoparticles. We had developed an assay using an ATR-FTIR method for quantiation and adsorption mechanism of polysorbate 80 on PLGA nanoparticles. Here we show the analytical validation of this method, for exploring its suitability for its intended purpose in industries. To comply with regulatory bodies and for standardization, we have followed the ICH and FDA guidelines for analytical validation and investigated the required criteria i.e. accuracy, precision, linearity, range ,limit of detection and quantitation. The method successfully complied with all regulatory criteria and is therefore suitable for successful use in industry, academia and by regulatory bodies.

History

Email Address of Submitting Author

akthakur@iitk.ac.in

Institution

Indian Institute of Technology Kanpur, India.

Country

India

ORCID For Submitting Author

0000-0002-7268-6836

Declaration of Conflict of Interest

There are no conflicts to be declared.

Version Notes

The discrepancy in the author's name has been corrected.

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