HPLC-MS/MS method for quantification of paclitaxel from keratin containing samples.
Local drug delivery of paclitaxel is becoming ever more prevalent. As complex drug/excipient combinations are being developed and tested, new high performance liquid chromatography-mass spectrometry (HPLC-MS) techniques capable of quantifying paclitaxel from such formulations are needed. Here a method for quantifying paclitaxel from aqueous, protein and oil containing samples was developed and validated. Keratin, derived from human hair, is the protein component/paclitaxel excipient in the development and validation of said method. The novelty of this method is described by its ability to overcome water solubility issues and address clean-up of residual solvents in clinical grade paclitaxel injection composition. The method evaluates tert-butyl methyl ether and ethanol as extraction solvents with an extraction efficiency of 31.9±2.3% and 86.4±4.5% respectively. Upon evaporation and rehydration, samples were evaluated by HPLC-MS and a method was developed for paclitaxel quantification. The method developed had an inter-day precision of 9.1% relative standard deviation and an intra-day precision of 4.3% relative standard deviation normalized to a docetaxel internal standard. The described method is applicable to any aqueous paclitaxel sample containing protein and/or oils.
Department of Mechanical Engineering, University of South Alabama, Mobile, AL 36688, USA.
Emily A
EA
Turner
Department of Chemistry, University of South Alabama, Mobile, AL 36688, USA.
Alexandra C
AC
Stenson
Department of Mechanical Engineering, University of South Alabama, Mobile, AL 36688, USA. Electronic address: syazdani@southalabama.edu.
Saami K
SK
Yazdani
D002851:Chromatography, High Pressure Liquid / Q000379:methods; D004337:Drug Carriers / Q000008:administration & dosage / Q000032:analysis*; D016503:Drug Delivery Systems / Q000379:methods; D007633:Keratins / Q000008:administration & dosage / Q000032:analysis*; D017239:Paclitaxel / Q000008:administration & dosage / Q000032:analysis*; D053719:Tandem Mass Spectrometry / Q000379:methods*
D004337:Drug Carriers; D007633:Keratins; D017239:Paclitaxel
Keratin; Keratose; Liquid chromatography; Mass spectrometry; Paclitaxel; Protein extraction