Simultaneous Pharmacokinetic Evaluation of Pantoprazole and Vitamin B Complex for Assessing Drug–Drug Interactions in Healthy Bangladeshi Adults by a Newly Developed and Validated HPLC Method

Abstract

The present study has been designed to evaluate the impact of the co-administration of pantoprazole (PNT) with vitamin B (VTB) complex (VTB comprising VTB1, VTB6, and VTB12 in this study) on pharmacokinetic behavior. In this study, HPLC-based sensitive and efficient methods for simultaneous determination in human plasma were developed per US-FDA bioanalytical standards. The pharmacokinetic parameters of PNT, VTB1, VTB6, and VTB12 were also evaluated when the medicines were administered alone and co-administered. Following linearity, it was observed that the plasma PNT, VTB1, VTB6, and VTB12 retention times were 6.8 ± 0.2, 2.7 ± 0.1, 5.5 ± 0.2, and 3.8 ± 0.1 min, respectively, over the range of 1−100 μg/mL. For all analytes at the lower limit of quantification and all other values, intra-assay and inter-assay bias were within 15% and 13.5%, respectively. They barely interacted when PNT and VTB samples were evaluated in physical combinations through in vitro tests. Moreover, in the pharmacokinetics study, treatment with VTB did not significantly alter the pharmacokinetic characteristics of PNT. Therefore, the current work’s results might help assess drug–drug interactions that may be applied to bioequivalence studies and therapeutic drug monitoring.

Keywords

• drug interactions
• HPLC
• pantoprazole
• pharmacokinetic
• vitamin B complex