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Maheswari .G*, Shantha kumari .K, Abdul Rahaman .S, Revathi .S, Neeharika .M

Dept. of Pharmaceutical Analysis, Nirmala college/Acharya Nagarjuna University, India


Liquid chromatography-mass spectrometry (LC-MS) is now became a routine technique with the development of electrospray ionisation (ESI) providing a simple and robust interface. It is applicable to a wide range of biological molecules and the use of tandem MS and stable isotope internal standards allows highly sensitive and accurate methods to be developed through some method optimisation to minimise ion suppression effects. The Method development of sound bioanalytical method(s) and its Method validation is of important during the process of drug discovery and development. The objective of this paper is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic (PK), toxicokinetic, bioavailability, and bioequivalence studies. Bioanalysis, employed for the quantitative determination of drugs and their metabolites in biological fluids, plays a significant role in the evaluation and interpretation of bioequivalence, PK, and toxicokinetic studies. Selective and sensitive analytical methods for quantitative evaluation of drugs and their metabolites are critical for the successful conduct of pre-clinical and/or biopharmaceutics and clinical pharmacology studies.


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