Validation of high performance liquid chromatography mass spectrometric method in positive ion mode for the estimation of Clopidogrel in human plasma using Clopidogrel D4 as internal standard

Abstract

The present project work was to develop a robust, rapid, simple and sensitive liquid chromatography mass spectrometry (LC-MS/MS) assay method for the quantification of clopidogrel in human plasma. A high performance liquid chromatography mass spectrometric method for the estimation of clopidogrel, in human plasma in positive ion mode was developed and validated using clopidogrel d4 as internal standard (is). Sample preparation was accomplished by solid phase extraction method. The eluted samples were chromatographed on kromasil 100 5c18, 100 x 4.6 mm, 5 µm (make: akzo nobel) using a mobile phase consisting of hplc grade acetonitrile: milli q/hplc grade water (90:10, v/v) the method was validated over a concentration range of 0.031 ng/ml to 15.077 ng/ml for clopidogrel. This validation report provides the results of analyte selectivity, matrix 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