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Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION BY LC-MS/MS: A REVIEW

Vijay Kumar S. Gupta*, Digambar N. Nalwad, Kishor L. Pere, Ajit Gite, Prathamesh Shinde and Amol Kendre

Abstract

LC-MS/MS is commonly used in laboratories for the qualitative and quant itative analysis of drug substances, drug products and biological samples. LC-MS/MS has played a significant role in evaluat ion and interpretation of bioavailability, bioequivalence and pharmacokinetic data. This article discuss about various extraction techniques like liquid–liquid extraction, solid phase extraction and protein precipitat ion which are important in the development of bioanalyt ical method. After developing a method with desired attributes, the method is validated to establish that it will continue to provide accurate, precise, and reproducible result during sample analysis. This review serves as a general guidance recommended for the validat ion of bioanalyt ical methods to ensure adequate reproducibility and reliability. The validation of bioanalyt ical methods and the analysis of study samples for clinical trials in humans should be performed following the principles of Good Clinical Pract ice (GCP). The stability of the method can be determined by several methods including freeze and thaw method, short termstability, bench-top stability, long termstability, stock solut ion stability and processed sample stability. The applications of LC-MS to the studies of in vitro and in vivo drug metabolism, analysis and identificat ion of impurit ies and degradation products in pharmaceut icals and analysis of chiral impurit ies in pharmaceut icals are described in this article.

Keywords: Bioanalytical Method Development, Validation, LC-MS/MS, Sample preparation, Extraction, Application.


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