Sample Preparation for Pharmaceuticals using A Bioanalytical Method: A Review

Abstract

The process of developing a method that will allow a compound of interest to be located and measured in a biological matrix is known as bioanalytical method development. A substance can frequently be measured using a variety of techniques, and selecting an analytical technique requires careful thought. Different extraction techniques, such as liquid-liquid extraction, solid phase extraction (SPE), and protein precipitation, are used to analyse drugs and their metabolites in a biological matrix. Samples from these extraction methods are spiked with calibration (reference) standards and quality control (QC) samples. The process of establishing if a quantitative analytical method is suitable for biomedical applications is known as bioanalytical method. includes all processes that will be presented measuring analytes quantitatively in particular biological samples such blood plasma, serum, or urine. To evaluate a drug's effectiveness and safety, clinical and non-clinical toxicokinetic and pharmacokinetic studies are used. Therefore, in order to produce accurate results, it is crucial that the applied bioanalytical procedures utilised are thoroughly defined, verified, and documented to a suitable quality. An overview of the development and validation of bioanalytical methods is given in this article, along with key considerations for each stage of method validation. The created procedure is then verified. Evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and pharmacodynamic investigations heavily rely on bioanalytical validations. where various parameters are carried out, including accuracy, precision, selectivity, sensitivity, reproducibility, and stability.