Development and clinical validation of HPLC method for precise quantification of paclitaxel in plasma from breast cancer patients
- 1Department of Pharmacy Practice, Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan
- 2Department of Medical Oncology, Dow University Hospital, Karachi, Pakistan
- 3Dow Institute of Biological, Biochemical and Pharmaceutical Sciences, Dow University of Health Sciences, Karachi, Pakistan
Abstract
A simple, reproducible, and green high-performance liquid chromatography (HPLC) method was developed and validated for the precise quantification of paclitaxel in plasma following an intravenous dose in patients with breast cancer. The proposed method is developed to enhance efficiency, offering significant advantages including rapid analysis, one-step extraction, low solvent consumption, and thorough validation with extensive parameters. Chromatographic analysis was performed using Schimadzu HPLC with LC solution software. Plasma proteins were precipitated using acetonitrile for efficient extraction of paclitaxel. A separation was achieved on C18 column with the mobile phase being a combination of acetonitrile and water in the combination of 65:35 (v/v). The method exhibited excellent linearity (with a correlation coefficient of 0.9999) over the concentration range of 0.375 μg/mL to 8 μg/mL. The lower limit of quantification was found to be 0.375 μg/mL. The accuracy and precision of the intra-day (96.87–99.65%) and inter-day (98.3–99.9%) assays, comply with accepted bioanalytical criteria. The recovery of paclitaxel from plasma ranged between 96.97 and 100%. Stability studies indicated that paclitaxel remained stable after 24 hours at room temperature and 4 weeks at −20°C. AGREE, AGREEprep, ComplexGAPI, AMVI, AMGS, and ESA tools confirmed the environmental friendliness and greenness of the proposed method. Furthermore, the method was successfully utilized in the pharmacokinetic investigation of paclitaxel in breast cancer patients. The determined values of Cmax were found comparable with reported values, confirming the method’s suitability for clinical pharmacokinetic study.
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BibTeX
@article{rahim2026development,
title = {{Development and clinical validation of HPLC method for precise quantification of paclitaxel in plasma from breast cancer patients}},
author = {Najia Rahim and Sadia Shakeel and Maryum Nouman and Sadia Asim and Javeria Chaudhry and Zulqarnain Hassan},
journal = {PLOS One},
year = {2026},
month = oct,
doi = {10.1371/journal.pone.0358891},
url = {https://doi.org/10.1371/journal.pone.0358891},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Development and clinical validation of HPLC method for precise quantification of paclitaxel in plasma from breast cancer patients
AU - Najia Rahim
AU - Sadia Shakeel
AU - Maryum Nouman
AU - Sadia Asim
AU - Javeria Chaudhry
AU - Zulqarnain Hassan
PY - 2026
DA - 2026/10/08
JO - PLOS One
DO - 10.1371/journal.pone.0358891
UR - https://doi.org/10.1371/journal.pone.0358891
AB - A simple, reproducible, and green high-performance liquid chromatography (HPLC) method was developed and validated for the precise quantification of paclitaxel in plasma following an intravenous dose in patients with breast cancer. The proposed method is developed to enhance efficiency, offering significant advantages including rapid analysis, one-step extraction, low solvent consumption, and thorough validation with extensive parameters. Chromatographic analysis was performed using Schimadzu HPLC with LC solution software. Plasma proteins were precipitated using acetonitrile for efficient extraction of paclitaxel. A separation was achieved on C18 column with the mobile phase being a combination of acetonitrile and water in the combination of 65:35 (v/v). The method exhibited excellent linearity (with a correlation coefficient of 0.9999) over the concentration range of 0.375 μg/mL to 8 μg/mL. The lower limit of quantification was found to be 0.375 μg/mL. The accuracy and precision of the intra-day (96.87–99.65%) and inter-day (98.3–99.9%) assays, comply with accepted bioanalytical criteria. The recovery of paclitaxel from plasma ranged between 96.97 and 100%. Stability studies indicated that paclitaxel remained stable after 24 hours at room temperature and 4 weeks at −20°C. AGREE, AGREEprep, ComplexGAPI, AMVI, AMGS, and ESA tools confirmed the environmental friendliness and greenness of the proposed method. Furthermore, the method was successfully utilized in the pharmacokinetic investigation of paclitaxel in breast cancer patients. The determined values of Cmax were found comparable with reported values, confirming the method’s suitability for clinical pharmacokinetic study.
SN - 1932-6203
ER -