A HPLC validated assay of paclitaxel’s related impurities in pharmaceutical forms containing Cremophor ® EL

A HPLC method has been developed for the determination of the paclitaxel’s related impurities in pharmaceutical forms. This method ensures the rapid determination of related impurities in the presence of polyoxyl castor oil—the main constituent of paclitaxel’s clinical formulation vehicle. The metho...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2004-02, Vol.34 (3), p.493-499
Hauptverfasser:	Ciutaru, Dana, Badea, Irinel, Lazar, Lelia, Nicolescu, Daniela, Tudose, Aurel
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Analytical, structural and metabolic biochemistry Biological and medical sciences Chromatography, High Pressure Liquid - methods Cremophor ® EL Drug Contamination Fundamental and applied biological sciences. Psychology General pharmacology Glycerol - analogs & derivatives Glycerol - analysis HPLC Medical sciences Paclitaxel Paclitaxel - analysis Pharmaceutical Preparations - analysis Pharmacology. Drug treatments Related impurities
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Beschreibung
Zusammenfassung:	A HPLC method has been developed for the determination of the paclitaxel’s related impurities in pharmaceutical forms. This method ensures the rapid determination of related impurities in the presence of polyoxyl castor oil—the main constituent of paclitaxel’s clinical formulation vehicle. The method is simple and does not require any preliminary treatment of the sample. The method was fully validated.
ISSN:	0731-7085 1873-264X
DOI:	10.1016/S0731-7085(03)00632-0