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 method is simple and does not require any preliminary treatment of the sample. The method was fully validated.
Ciutaru
Dana
D
Sindan Pharmaceutical Co., 11 Ion Mihalache Blvd., 78168 Bucharest, Romania.
Badea
Irinel
I
Lazara
Lelia
L
Nicolescu
Daniela
D
Tudose
Aurel
A
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004340:Drug Contamination; D005990:Glycerol / Q000031:analogs & derivatives* / Q000032:analysis*; D017239:Paclitaxel / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis
D004364:Pharmaceutical Preparations; C000515:cremophor EL; D017239:Paclitaxel; D005990:Glycerol