Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF VARENICLINE TARTRATE USING K3EDTA HUMAN PLASMA BY LC-ESI-MS/MS

Tarun Sen*, Rakesh Patel and Jeevan Patel

ABSTRACT

LC-ESI-MS/MS in new era of bioanalytical study for broad organization and clinical research changes the area with identification. In method development and validation LC-ESI-MS/MS recognize the analyte with their molecular mass and concentration to estimate impurities. Pharmacokinetic data analysis by using human plasma and other like serum study in bioanalysis now a days increase. The aim of this study to method development and validation of varenicline tartrate. Varenicline tartrate is used in smoking cessation. It is an alternative to nicotine replacement therapies and has great efficacy than them in comparable studies. It is the first non-nicotinic-containing medication developed with the sole purpose of treating nicotine addiction. All the important parameters for method validation are discuss here and perform as per the GCP and GLP guidelines. Parameters like system
suitability and system performance also performed to specify the instrument performance and suitability of HPLC and Mass Spectrometry. Identified procedure of extract and un-extract samples of specified parameters always recognize exact method for study. It should be considered that every special step of taking validation during in-process is free form the contamination zone. Our performance area of lab follows guidelines and SOP to consider how to perform in specified manner. Majority of data in the manner of specific development procedure and method those give better accuracy and result of the study for method validation.

Keywords: Bioanalytical, Method Validation, Method Development, Varenicline Tartrate.