Abstract
DEVELOPMENT AND VALIDATION OF A LC-MS/MS METHOD FOR MESALAMINE IN HUMAN PLASMA BY DERIVATIZATION TECHNIQUE

Edem Balaraju*, Mahesh Meghavath, Venkataiah Bhootham

ABSTRACT

A simple, specific, accurate, precise and rugged liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quantification of Mesalamine in human plasma, with Mesalamine D3 as an internal standard (IS). The analyte was extracted by protein precipitation method and separated on a Thermo, Hypersil BDS, C18, 100 mm × 4.6 mm, 5 μm, column. The mobile phase was composed of 0.1% formic acid in water: acetonitrile in the ratio of 40:60 as a mobile phase at a flow rate of 0.5mL/min in isocratic. Mesalamine and Mesalamine D3 were ionized in positive polarity and detected in the multiple reaction monitoring mode (MRM) using m/z 210.1→192.1, and m/z 213.1→195.1 for Mesalamine and Mesalamine D3 respectively. Method Validation concentration range 10-1200 ng/mL. It is concluded that successfully completed the method development and validation.

Keywords: Mesalamine, Mesalazine, 5-ASA, LC-MS/MS.


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