A review on bioanalytical method development and pre-method validation concepts using SPE and LLE process by LC-MS/MS method

Abstract

The review article provides guidance for the development of a Bio-Analytical Method intended for the estimation of drugs in biological fluids. The development of a suitable analytical method for the identification, isolation and quantification of different drugs and or their metabolites from biological fluids is an essential and challenging component of pharmacokinetic studies. The uses of detection techniques that are highly sensitive and specific for the quantification of drugs and or metabolites in biological fluids are preferred. To collect the information on physiochemical, pharmacokinetic, chromatographic and extraction procedures of the drug/Metabolites from available sources, e.g. Medline, Journals, Analytical abstract, Physician Desk Reference, Library etc. Summarize the physiochemical, pharmacokinetic properties, chromatographic and extraction procedures. Select the equipment according to the availability and sensitivity. Select the initial chromatographic conditions and also identify the extraction. The selection of Internal standard should be similar to the analyte. Prepare the required solutions and stock dilutions at the required concentration. Tune the instrument with suitable solutions and optimize parameters for Q1/Q3 ions. Condition the system and column with the selected mobile phase. Perform pre-method validation experiments. Select the best weighing factors for the standards. Compile all the chromatograms and raw data and archive since the development of a Bio-Analytical method for a given drug is so essential to start with, this guidance for approaching and conclude for a suitable method that later can be validated. It is important to note that this is intended to identify minimal criteria for producing consistent and comparable data. This procedure is applicable to the methods that are to be developed for the estimation of drugs and metabolites from biological fluids using any chromatographic devices in the Bio- Analytical Department.