RP-HPLC bioanalytical Method of Itopride hydrochloride for determination and its Pharmacokinetic applications

Abstract

Itopride hydrochloride (ITH) is currently used for the management of acute prokinetic disorders. In recent research, the determination of ITH in plasma, a new economic, prompt, and isocratic RP-HPLC bioanalytical approach, was established. This method is valid for quantifying the low concentration of drugs in plasma trials which is the demand to be improved. A HILIC column with a separation phase of MeOH: Buffer (30:70 v/v) and a flow with one millilitre per minute, as well as a UV sensor at 258nm, was used to achieve chromatographic high separation. The pharmacokinetic parameters were determined using blood from rabbits after administration of oral suspension containing ITH particles (1mg/kg). The retention time for both ITH and ornidazole, an internal standard (IS), was found to be 6.249min and 4.843 respectively. The statistical interpretation of the results was confirmed. The linearity assortment of the drug was 2-15µg/mL, and the recovered ITH and IS were found to be 100.1% and 99.8% with accuracy, whereas the analysis of the sample was 99.87%, respectively. In addition, the oral pharmacokinetic parameters were successfully analyzed by using this method for ITH and OND. The highest plasma concentration (Cmax) of ITH was 6.805 (mcg/mL) at (Tmax) 1hr and half-life was found at 4.022 hours, correspondingly. The present analytical method has been efficiently used to study the pharmacokinetics of drug combinations.