STEROID HORMONE DRUGS LIQUID CHROMATOGRAPHY - TANDEM MASS SPECTROMETRY

Bioanalysis of drug substance and drug product is a subdiscipline of analytical chemistry for the quantitative determination of drugs in biological matrix such as whole blood, plasma, serum, tissue and urine. It has witnessed a remarkable flow, both in the development of more selective and effective drugs and in understanding their therapeutic and toxic effects. Knowledge of drug levels in body fluids allows the optimization of pharmacotherapy and provides a basis for the evaluation and interpretation of patient compliance, bioavailability, bioequivalence and pharmacokinetics. Pharmacokinetic and bio-equivalency studies require very precise and accurate assay methods that are well validated to quantify drugs in biological samples. The assay methods have to be sensitive enough to determine the biological sample concentration of the drug and/or its metabolite(s) for a period of about five elimination half-lives after dosage of the drug. The assay methods also have to be very selective to ensure reliable data, free from interference of endogenous compounds in the biological samples. In addition, methods have to be as robust and cost effective as possible.