1Department of Pharmaceutical Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik422102
2Department of Pharmaceutical Chemistry, PRES College of Pharmacy (Women’s), Chincholi, Nashik-422102
In this review article, bioanalytical techniques are often employed to quantify pharmaceuticals and their metabolites in plasma matrices, and the techniques should be used in both human clinical investigations and nonhuman research. A key component of estimate and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic investigations is the use of the bioanalytical technique for the quantitative measurement of medicines and their metabolites in biological medium. Method creation, method validation, and sample analysis are the three main responsibilities of bioanalysis. To determine the amount to which environment, matrix, or procedural factors might affect the estimation of analyte in the matrix from the time of set up to the time of analysis, each step in the technique must be examined. Techniques such as high-pressure liquid chromatography (HPLC) and liquid chromatography coupled with double mass spectrometry (LCMS-MS) can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanalysis of small/ large molecules, with LC/MS/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug, concentration and its metabolite.
Neha Gaikwad*, Kanchan Shinde, Varsha Pangale, Charushila Bhangale, Bioanalytical Method Development And Validation For The Estimation Of Active Pharmaceuticals In Dosage Forms, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 3, 143-152. https://doi.org/10.5281/zenodo.7755584