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International Journal of Analytical Chemistry
Volume 2013 (2013), Article ID 135613, 11 pages
http://dx.doi.org/10.1155/2013/135613
Research Article

Liquid Chromatography/Tandem Mass Spectrometry Method for Quantitation of Cremophor EL and Its Applications

Department of Pharmacy, Jagadishprasad Jhabermal Tibrewala University, Vidyanagari, Jhunjhunu, Rajasthan 333001, India

Received 25 February 2013; Revised 12 April 2013; Accepted 24 April 2013

Academic Editor: Frantisek Foret

Copyright © 2013 V. Vijaya Bhaskar and Anil Middha. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A rapid sensitive and selective MRM based method for the determination of Cremophor EL (CrEL) in rat plasma was developed using liquid chromatography/tandem mass spectrometry (LC-MS/MS). CrEL and polypropylene glycol (internal standard) were extracted from rat plasma with acetonitrile and analysed on C18 column (XBridge, 50 × 4.6 mm, 3.5 μm). The most abundant molecular ions corresponding to PEG oligomers at m/z 828, 872, 916 and 960 with daughter ion at m/z 89 were selected for multiple reaction monitoring (MRM) in electrospray mode of ionisation. Plasma concentrations of CrEL were quantified after administration through oral and intravenous routes in male sprague dawley rats at a dose of 0.26 g/kg. The standard curve was linear (0.9972) over the concentration range of 1.00 to 200 μg/mL. The lower limit of quantitation for CrEL was 1.00 μg/mL using 50 μL plasma. The coefficient of variation and relative error for inter and intra assay at three QC levels were 0.69 to 9.21 and −7.60 to 4.74 respectively. A novel proposal was conveyed to the scientific community, where formulation excipient can be analysed as qualifier in the analysis of NCEs to address the spiky plasma concentration profiles.