Dr M.sunitha1*, Nabila Quddus2, Naila Sadiq3, Dr R. Vani4*
1Principal, Shadan Women’s College of Pharmacy, Hyderabad, India
2Post graduate student, Shadan Women’s College of Pharmacy, Hyderabad, India
3Post graduate student, Shadan Women’s College of Pharmacy, Hyderabad, India
4Head of the department, Pharmaceutical Analysis, Shadan Women’s College Of Pharmacy, Hyderabad, India
Bioanalytical methods are used for the quantitative analysis of drugs and their metabolites in the biological media like plasma, serum etc. Pharmacokinetic parameters are important consideration for many drugs and its metabolites hence validation of this method is necessary. There are different interrelated parts in bioanalytical method development such as sample preparation, chromatographic separation and spectrometry detection by using proper analytical method. Validation of a Bioanalytical method is the process by which it is established that the performance characteristics of the method meet the requirements for the intended Bioanalytical application. The validation is further divided into full validation, partial validation, and cross validation each of which has its own purpose. In this, we focus on the consistent evaluation of the key bioanalytical validation parameters: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery, quality control and stability. These validation parameters are described, along with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and EMA guidelines. The data obtained from these methods is required in the pharmacokinetic and toxicokinetic studies of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
Key words: Bio-analytical method development, LC-MS, validation.