HPLC-MS/MS method for quantification of paclitaxel from keratin containing samples

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Biomaterials

Background:

• Local drug delivery systems for paclitaxel are increasingly common.
• Complex formulations require advanced analytical methods for accurate quantification.
• Existing methods may struggle with solubility and residual solvent analysis.

Purpose of the Study:

• To develop and validate a novel HPLC-MS method for paclitaxel quantification.
• To address challenges in analyzing paclitaxel within aqueous, protein- and oil-containing samples.
• To create a robust method for complex injectable formulations.

Main Methods:

• Evaluation of tert-butyl methyl ether and ethanol as extraction solvents.
• Development of a sample preparation protocol involving evaporation and rehydration.
• Quantification using high-performance liquid chromatography-mass spectrometry (HPLC-MS) with docetaxel as an internal standard.
• Validation of the method for precision and accuracy.

Main Results:

• Ethanol demonstrated superior extraction efficiency (86.4±4.5%) compared to tert-butyl methyl ether (31.9±2.3%).
• The validated HPLC-MS method achieved good precision: 9.1% inter-day and 4.3% intra-day relative standard deviation.
• The method successfully quantified paclitaxel in samples containing protein (keratin) and oils.

Conclusions:

• A novel and validated HPLC-MS method enables accurate paclitaxel quantification in complex aqueous formulations.
• The method overcomes common challenges like poor water solubility and residual solvent interference.
• This analytical approach is applicable to various paclitaxel delivery systems containing proteins and oils.