The removal of Cremophor® EL from paclitaxel for quantitative analysis by HPLC-UV

UNCW Author/Contributor (non-UNCW co-authors, if there are any, appear on document)
James D. Perdue (Creator)
The University of North Carolina Wilmington (UNCW )
Web Site:
Robert Hancock

Abstract: The most common technique for analysis of drug substances is high performance liquid chromatography (HPLC) using a variable wavelength detector (UV). Cremophor® EL (ethoxylated castor oil, CrEL) is a non-ionic emulsifier that is used to assist in the solubilization of hydrophobic drugs such as the antineoplastic agent, paclitaxel. However, the molecular weight distribution of CrEL creates difficulties in the analysis of potency and related substances of hydrophobic drugs via UV detection. Using a precipitation method, CrEL was selectively removed from the paclitaxel by pre-treating the injectable dosage form with mercuric chloride and analyzing the filtered extract by HPLC-UV. The removal of CrEL from the injectable dosage form of paclitaxel by precipitation with mercuric chloride resulted in a solution that was suitable to quantitate active and related substances by HPLC-UV. The precipitate was then characterized by nuclear magnetic resonance, infrared spectrophotometry and x-ray diffraction to elucidate its mechanism of action. The combination of these analyses provided sufficient evidence that the complex formed between CrEL and mercuric chloride is from the coordination of the mercury atom to the ether oxygens present in the CrEL.

Additional Information

A Thesis Submitted to the University of North Carolina Wilmington in Partial Fulfillment Of the Requirements for the Degree of Master of Science
Language: English
Date: 2009
Antineoplastic agents--Analysis, Drugs--Solubility, Drugs--Spectra, Drugs--Structure-activity relationships, High performance liquid chromatography, Liquid chromatography, Mercuric chloride, Paclitaxel--Separation, Pharmaceutical chemistry--Methods
Liquid chromatography
Drugs -- Structure-activity relationships
Pharmaceutical chemistry -- Methods
Drugs -- Solubility
Paclitaxel -- Separation
Antineoplastic agents -- Analysis
Drugs -- Spectra
Mercuric chloride
High performance liquid chromatography

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