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 microm, 80 A column with an isocratic mobile phase composed of 10 mM ammonium acetate (pH 7.10): acetonitrile (30:70, v/v), pumped at 0.6 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) > or = 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.
Challa
Balasekhara R
BR
Dept of Chemistry, Jawaharlal Nehru Technological University, Anantapur 515002, A.P., India. baluchalla_99@yahoo.com
Boddu
Sai H S
SH
Awen
Bahlul Z
BZ
Chandu
Babu R
BR
Bannoth
Chandrasekhar K
CK
Khagga
Mukkanti
M
Kanala
Kanchanamala
K
Shaik
Rihana P
RP
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000097:blood* / Q000737:chemistry; D000704:Analysis of Variance; D019540:Area Under Curve; D002853:Chromatography, Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D000077402:Pantoprazole; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000077402:Pantoprazole