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Validated HPLC method for paclitaxel determination in PLGA submicron particles conjugated with α-fetoprotein third
M Sokol1, V Zenin2, N Yabbarov1
1Russian Research Center for Molecular Diagnostics and Therapy, 117638 Moscow, Russian Federation; Institute of Biochemical Physics, RAS, 119334 Moscow, Russian Federation.
Annales Pharmaceutiques Francaises
|February 12, 2021
Summary
This study developed and validated an HPLC method for precise paclitaxel (Ptx) determination in protein-conjugated PLGA submicron particles. The method enables accurate quantification of Ptx encapsulation and drug loading in novel drug delivery formulations.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Nanotechnology
Background:
- Paclitaxel (Ptx) is a crucial chemotherapeutic agent.
- PLGA submicron particles conjugated with protein vectors offer advanced drug delivery potential.
- Accurate quantification of Ptx is essential for characterizing these novel formulations.
Purpose of the Study:
- To develop a robust sample preparation technique for Ptx analysis.
- To validate a High-Performance Liquid Chromatography (HPLC) method for precise Ptx determination.
- To quantify Ptx encapsulation efficiency and drug loading in protein-conjugated PLGA submicron particles.
Main Methods:
- PLGA submicron particles loaded with Ptx were prepared using a single emulsification method.
- Particles were conjugated with alpha fetoprotein third domain (rAFP3d) via carbodiimide chemistry.
- HPLC analysis was performed using a C-18 column with UV-Vis detection; sample preparation involved DMSO pre-dissolution and centrifugation.
Main Results:
- An efficient sample preparation involved 4% DMSO pre-dissolution and 10 min centrifugation at 4500g.
- The HPLC method demonstrated linearity from 0.03 to 360 μg/mL, with LOD/LOQ of 0.005/0.03 μg/mL.
- Excellent intra- and inter-day precision (RSD < 2%) was achieved.
Conclusions:
- The validated HPLC method provides accurate and precise determination of Ptx.
- The method is suitable for calculating Ptx encapsulation efficacy and drug loading.
- This analytical approach supports the development of Ptx-loaded, protein-conjugated PLGA nanoparticles.
