Development and validation of a Sensitive bioanalytical method for the quantitative estimation of Pantoprazole in human plasma samples by LC-MS/MS: Application to bioequivalence study

The present study aims at developing a simple, sensitive and specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantification of pantoprazole sodium (PS) in human plasma using pantoprazole D3 (PSD3) as internal standard (IS). Chromatographic separation was performed on Zorbax SB-C18, 4.6 mm x 75 mm, 3 5 mu m, 80 angstrom column with an isocratic mobile phase composed of 10 mM ammonium acetate (pH 7 10) acetonitrile (30 70, v/v), pumped at 06 mL/min PS and PSD3 were detected with proton adducts at m/z 384 2 -> 200 1 and 387.1 -> 203 1 in multiple reaction monitoring (MRM) positive mode. respectively Precipitation method was employed in the extraction of PS and PSD3 from the biological matrix This method was validated over a linear concentration range of 10 00-3000 00 ng/mL with correlation coefficient (r) >= 0 9997. Intra- and inter-day precision of PS were found to be within the range of 1 13-1.54 and 1.76-2 86, respectively Both analytes were stable throughout freeze/thaw cycles, bench top and postoperative stability studies. This method was successfully utilized in the analysis of blood samples following oral administration of PS (40 mg) in healthy human volunteers (C) 2010 Elsevier B V All rights reserved.