An Overview of the Development and Validation of Bioanalytical Methods using HPLC

A key component of successful drug development is the creation of sensitive, dependable, and selective bioanalytical techniques for the quantitative assessment of medications and their metabolites in biological matrices. The pharmacokinetic and toxicokinetic analyses of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs) all require the data gathered from these techniques. Critical judgments supporting a drug's safety and efficacy are based on the findings of human clinical trials, including bioavailability and bioequivalence studies that require pharmacokinetic evaluation, as well as animal toxicokinetic research. Therefore, in order to acquire accurate results, it is crucial that the proposed bioanalytical procedures be well-designed, sufficiently validated, and documented to a satisfactory quality for application in drug analysis. A flexible analytical method for identifying and quantitatively estimating low concentrations of medications and metabolites in biological matrices is high pressure liquid chromatography. Therefore, developing and validating a bioanalytical HPLC approach for low-dose medicines is beneficial. This article examines recent developments in the creation of bioanalytical methods based on HPLC and the validation of various medications. Thus far, bioanalytic analysis has been performed on medications such as Omeprazole, Clofarabine, Palonosetron HCl, and antimalarials.