Determination of Uncojugated and total Ezetimibe in Human Plasma and its Application to Pharmacokinetic Studies

Abstract

The pharmacological response is generally related to the concentration of drug newlineat receptor site (Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations, USFDA, 2003).The newlineavailability of a drug from the dosage form is a critical element of drug efficacy (Guidelines for Bioavailability and Bioequivalence Studies, CDSCO, 2005). newlineHowever, drug concentrations usually, cannot be readily measured directly at the site of action; therefore most bioavailability studies involve the determination of drug concentration in the biological matrix like blood, plasma, urine etc. This is based on the premise that the drug at the site of action is in equilibrium with drug in blood. It is therefore possible to obtain an indirect measure of drug response by monitoring drug level in biological matrix. The bio-analysis employed for the quantitative newlinedetermination of drug and metabolites in biological fluids plays a significant role in the evaluation of bioequivalence, pharmacokinetic and toxicological studies.