Abstract
BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MONOMETHYL FUMARATE BY LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY AND ITS APPLICATION TO A PHARMACOKINETIC STUDY

V. Satish Ramanatham*, P. Venkateswarlu, Y. Siva Sankar Rao and Konda Ravi Kumar

ABSTRACT

The present research work was to develop a robust, rapid, simple and sensitive liquid chromatography–tandem mass spectrometry (LC-MS/MS) assay method for the quantification of monomethyl fumarate in human plasma. An analytical method employing LC-MS/MS using human plasma was developed and fully validated for the estimation of Monomethyl fumarate. Stable labeled isotopes are used for the quantification of these drugs. The solid phase extraction technique (SPE) was used for the extraction of the drug and Internal standard (IS). The chromatographic separation was achieved on a Zodiac C18 column by using a 70:30 (v/v) mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 0.5 mL/min. Totally five precision and accuracy batches were performed during the entire validation and intra-day and inter-day precision and accuracy were proved.

Keywords: Monomethyl fumarate, Human plasma, LC–MS/MS, Pharmacokinetics, Quantification.


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