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

作者：Challa Balasekhara R; Boddu Sai H S; Awen Bahlul Z; Chandu Babu R; Bannoth Chandrasekhar K^*; Khagga Mukkanti; K****a Kanchanamala; Shaik Rihana P

来源：Journal of Chromatography B-Analytical Technologies in the Biomedical and Life Sciences, 2010, 878(19): 1499-1505.

DOI：10.1016/j.jchromb.2010.03.0049

• Mass spectrometry
• Bioequivalence
• Pantoprazole

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.

• 出版日期2010-6-1