The metamorphosis of analytical chemistry
Bioanalytical method development is the process of creating a procedure to enable a compound of interest to be identified and quantified in a biological matrix. A compound can often be measured by several methods and the choice of analytical method involves many considerations. Analysis of drugs and their metabolites in a biological matrix is carried out using different extraction techniques like liquid-liquid extraction, solid phase extraction (SPE) and protein precipitation from these extraction methods samples are spiked with calibration (reference) standards and using quality control (QC) samples. These methods and choice of analytical method describes the process of method development and includes sampling, sample preparation, separation, detection and evaluation of the results. The developed process is then validated. These bioanalytical validations play a significant role in evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic studies. In which different parameters like accuracy, precision, selectivity, sensitivity, reproducibility, and stability are performed
Analytical methods development and validation play important roles in the discovery, development and manufacture of pharmaceuticals. The official test methods that result from these processes are used by quality control laboratories to ensure the identity, purity, potency and performance of drug products 1 and includes all the procedures demonstrating particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, reliable and reproducible for the intended use. The recent studies show that sample throughput is an important part in Bioanalytical method development involving an efficient preparation.
The analysis thus carried out must be verified for its alleged purpose and must be validated. An investigation should be performed during each step to determine whether the external environment, matrix or procedural variables can affect the estimation of analyte in the matrix from the time of collection up to the time of analysis. Recent progress in methods development has been largely a result of improvements in analytical instrumentation.
This is true especially for chromatographs and detectors. Isocratic and gradient high-performance liquid chromatography (HPLC) have evolved as the primary techniques for the analysis of non-volatile active pharmaceutical ingredients and impurities. The emphasis on the identification of analytes and impurities has led to the increased use of hyphenated techniques such as liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-nuclear magnetic resonance spectroscopy (LC-NMR). The 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.
Journal of Analytical and Bioanalytical Techniques