Abstract

METHOD DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY MASSSPECTROMETRIC METHOD FOR THE ESTIMATION OF LUMEFANTRINE IN POSITIVE ION MODE IN HUMAN PLASMA USING LUMEFANTRINE D18 AS INTERNAL STANDARD

Shaik Jakeer Hassan* and Syed Munner

ABSTRACT

A high performance liquid chromatography mass spectrometric method for the estimation of Lumefantrine, in human plasma in Positive ion mode was developed and validated using Lumefantrine d18 as internal standard (IS). Sample preparation was accomplished by Liquid-Liquid extraction technique. The reconstituted samples were chromatographed on Zorbax Eclipse XDB-C8, 150 x 4.6 mm, 5.0 μm (Make: Agilent Technologies) column using a mobile phase consisting of HPLC grade methanol: acetonitrile: 0.1% formic acid (50:30:20, v/v/v). The method was validated over a concentration range of 50.239 ng/mL to 20027.843 ng/mL for Lumefantrine. This validation report provides the results of selectivity, matrix effect, sensitivity determinations, calibration standards and quality control samples data, precision and accuracy data, the results of recovery, various stabilities, run size evaluation and dilution integrity along with all pertinent documentation.

Keywords: HP-LCMS (High Performance Liquid Chromatography Mass Spectrometry), Lumefantrine, Human Plasma in Positive ion mode, Lumefantrine d18 internal standard.