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Development and validation method for estimation paclitaxel in plasma.

Emna Gaïes, Nadia Jebabli, Dorra Ben Said

La Tunisie Medicale

|January 22, 2021

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A new HPLC-UV method accurately quantifies paclitaxel (PTX) in plasma, aiding therapeutic drug monitoring for this vital anticancer agent. This reliable assay ensures precise PTX level measurements for improved patient outcomes.

Area of Science:

Analytical Chemistry
Pharmacokinetics
Clinical Chemistry

Background:

Paclitaxel (PTX) is a crucial anticancer drug with a narrow therapeutic index.
Significant inter-individual variability in PTX pharmacokinetics necessitates precise monitoring.
Hematological toxicity is a key concern in PTX treatment.

Purpose of the Study:

To develop and validate a novel, rapid, and reliable method for quantifying paclitaxel (PTX) in human plasma.
To establish a sensitive assay for therapeutic drug monitoring (TDM) of PTX.

Main Methods:

High-Performance Liquid Chromatography (HPLC) with UV detection was employed.
Liquid-liquid extraction was used for sample preparation.
Chromatographic separation was performed on an RP 18 column with a mobile phase of acetonitrile and potassium dihydrogenophosphate.

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Main Results:

The developed HPLC-UV method demonstrated linearity over a concentration range of 50-1500 ng/mL (r=0.998).
The assay exhibited good precision, with within-day coefficients of variation (CV) from 6.94% to 18.78% and day-to-day CVs below 15%.
Analysis time per sample was efficient, not exceeding 12.81 minutes.

Conclusions:

A sensitive, specific, and reliable HPLC-UV assay for paclitaxel (PTX) quantification in plasma has been successfully developed and validated.
This method is suitable for routine clinical use in therapeutic drug monitoring of PTX.
The assay facilitates precise monitoring of PTX levels, potentially improving treatment efficacy and safety.