Simple bioanalytical method development and validation of micronised Domperidone 20 mg tablets using LCMS-MS and its pharmacokinetic application in Healthy Indian Volunteers

Abstract

The current investigation deals with an validated Liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) analytical method for the quantification of micronised domperidone in plasma of human volunteers. The validation of LC-MS/MS method was accomplished by evaluating the inter-day and intra-day precision and accuracy in a linear concentration range of 3.33-100 ng/ml. The entire study was an attempt to evaluate the comparison index of the bioavailability study of micronised domperidone tablet formulation with that of conventional domperidone tablet containing 20 mg of domperidone. Both the formulations were given orally as a single dose cross over design. The washout period was taken as 1 week. A single-dose, two-sequence, two-treatment, two-period crossover Bioequivalence study of two formulation were performed on 12 Indian healthy male volunteer. The estimation of domperidone concentration in human plasma was determined by the validated LC-MS/MS method. The various pharmacokinetics parameters like peak plasma concentration (C max), and time to reach peak plasma concentration (t max), area under the plasma concentration-time curve (AUC 0-t), area under the plasma concentration-time curve from zero to infinity (AUC 0-∞), of both the formulations were evaluated and compared. The results evaluated by estimated pharmacokinetic parameters did not find any statistically significant difference between the two formulations. The relative bioavailability of micronized test formulation was found to be 104.62% to that of reference conventional formulation.