Development and validation of a rapid RP-HPLC method for simultaneous quantification of paclitaxel and cetuximab in immunoliposomes

Author(s)

Ribeiro de Souza, Ana Luiza ^[1] ; Ferreira Amorim, Amanda Claudia ^[1] ; Cintra, Emilio Ramos ^[1] ; Ferreira, Natalia Noronha ^[2] ; Dantas Silva, Luis Antonio ^[1] ; Hayasaki, Tacio Goncalves ^[1] ; Almeida Diniz, Danielle Guimaraes ^[1] ; Lima, Eliana Martins ^[1]

Affiliation

^[1] Univ Fed Goias, Sch Pharm, Lab Pharmaceut Nanotechnol & Drug Delivery Syst F, Goiania, Go - Brazil

^[2] Sao Paulo State Univ, Sch Pharmaceut Sci, UNESP, Araraquara, SP - Brazil

• Document type: Journal article
• Source: Talanta; v. 225, APR 1 2021.
• Web of Science Citations: 0

Abstract

The development of rational therapies against complex diseases, such as cancer, has increased in the past few years due to the advances of `omics' technologies. Concomitantly, several efforts have been made to design sophisticated drug delivery systems in order to increase specificity and drug accumulation in tumor sites. The complexity of these drug delivery systems highlights the need for suitable analytical methods to determine encapsulation/conjugation efficiency of drugs and molecules responsible for the targeted delivery. Therefore, this study focuses on the development and validation of a RP-HPLC-DAD methodology for concurrent quantification of paclitaxel (PTX) and cetuximab (CTX) in immunoliposomes. Chromatographic separation was achieved using a wide pore C-8 column, and a gradient mobile phase consisting of 0.1% trifluoroacetic acid (TFA) in Milli-Q water/acetonitrile/isopropanol with a flow rate of 1 mL min(-1). Drug peaks were fully separated and detected at 280 nm using UV detector. The method was validated according to ICH and FDA guidelines in terms of specificity and forced degradation studies, system suitability, linearity, limit of detection, limit of quantification, repeatability, intermediate precision, accuracy, robustness, and short-term stability. The developed method was linear over the concentration range of 37.5-150 mu g mL(-1) of PTX and 75-300 mu g mL(-1) of CTX. All parameters evaluated satisfied the acceptance criteria, according to both FDA and ICH guidelines. The applicability of the analytical method was assessed following the development of PTX-loaded immunoliposomes conjugated with CTX. Thus, the present study shows a novel, simple, stability-indicating and suitable method to quantify simultaneously PTX and CTX in immunoliposomes. (AU)

• FAPESP's process: 18/04546-1 - Evaluation of synergic effect between CHC and cetuximab against glioblastoma using drug delivery systems
• Grantee: Natália Noronha Ferreira Naddeo
• Support Opportunities: Scholarships abroad - Research Internship - Doctorate
• FAPESP's process: 16/09671-3 - Nanostructured multifunctional systems for drug controlled release through nasal route on glioblastomas treatment
• Grantee: Natália Noronha Ferreira Naddeo
• Support Opportunities: Scholarships in Brazil - Doctorate