Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Validated Lc-Ms/Ms Assay for the Quantitative Determination of Fenretinide in Plasma and Tumor and Its Application to Pharmacokinetic Study in Mice of a Novel Oral Nanoformulation of Fenretinide

Cristina Matteo
ORCID logo ,
Isabella Orienti
ORCID logo ,
Adriana Eramo
,
Ann Zeuner
ORCID logo ,
Mariella Ferrari
,
Alice Passoni
ORCID logo ,
Renzo Bagnati
ORCID logo ,
Marianna Ponzo
,
Ezia Bello
ORCID logo ,
Massimo Zucchetti
* ORCID logo ,
Roberta Frapolli
ORCID logo
Version 1 : Received: 20 February 2024 / Approved: 21 February 2024 / Online: 22 February 2024 (01:40:14 CET)

A peer-reviewed article of this Preprint also exists.

Matteo, C.; Orienti, I.; Eramo, A.; Zeuner, A.; Ferrari, M.; Passoni, A.; Bagnati, R.; Ponzo, M.; Bello, E.; Zucchetti, M.; Frapolli, R. Validated LC-MS/MS Assay for the Quantitative Determination of Fenretinide in Plasma and Tumor and Its Application in a Pharmacokinetic Study in Mice of a Novel Oral Nanoformulation of Fenretinide. Pharmaceutics 2024, 16, 387. Matteo, C.; Orienti, I.; Eramo, A.; Zeuner, A.; Ferrari, M.; Passoni, A.; Bagnati, R.; Ponzo, M.; Bello, E.; Zucchetti, M.; Frapolli, R. Validated LC-MS/MS Assay for the Quantitative Determination of Fenretinide in Plasma and Tumor and Its Application in a Pharmacokinetic Study in Mice of a Novel Oral Nanoformulation of Fenretinide. Pharmaceutics 2024, 16, 387.

Abstract

We describe the development and validation of a HPLC-MS/MS method to assess the pharmacokinetics and tumour distribution of fenretinide, a synthetic retinoid chemically related to all-trans-retinoic acid, after administration of a novel oral nanoformulation of fenretinide, called bionanofenretinide (BNF). BNF was developed to overcome the major limitation of fenretinide: its poor aqueous solubility and bioavailability due to its hydrophobic nature. The method proved to be reproducible, precise, and highly accurate for the measurement of the drug and the mains metabolites. The lower limit of quantification resulted 1 ng/mL. The curve range of 1-500 ng/mL and 50-2000 ng/mL, for plasma and tumor homogenate respectively, was appropriate for the analysis, as demonstrated by the accuracy between 96.8% and 102.4% for plasma and 96.6-102.3% for tumor. The inter-days precision and accuracy determined on quality controls at 3 different levels were in ranges of 6.9%-7.5% and 99.3-101.0% and 0.96-1.91% and 102.3-105.8% for plasma and tumour, respectively.

Keywords

Fenretinide; 4-HPR; oral formulation; pharmacokinetics; tumour distribution; analytical chemistry

Subject

Biology and Life Sciences, Life Sciences

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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