Hazards in chromatographic bioanalysis method development and applications

Abstract

Bioanalytical methods are employed for the quantitative determination of drugs and their metabolites in biological matrices, in all stages of the drug development process. However, because of the highly complex nature of these matrices there is a wide range of potential biological, chemical and physical hazards that can influence the quality of the data produced by these methods. The present review focuses on the evaluation of the most important and frequent errors that may be encountered during bioanalytical method development/validation and analysis of clinical or preclinical samples mainly using chromatography. Additionally, the most practical ways for avoiding and managing these hazards during routine bioanalysis are presented.

Purification of hyaluronidase as an anticancer agent inhibiting CD44

“…All of the purification protocols reported show that the cost of the column used was high. Thus for the purification of proteins, affinity chromatography is more reasonable than other alternative strategies (Abdolalizadeh et al, , Hooshfar & Bartlett, ). Using multiple columns is not appropriate for the purification of Hyal and thus cannot be used at the industrial level.…”

Sample preparation for large‐scale bioanalytical studies based on liquid chromatographic techniques

“…Generally, entire bioanalytical studies should be validated according to widely accepted criteria to ensure they provide reliable data during their routine application. Some widely accepted guidelines for bioanalytical method validation are the Guidelines on Bioanalytical Method Validation () by the European Medicines Agency and the Guidance for Industry, Bioanalytical Method Validation (), by the United States Food and Drug Administration (Hooshfar & Bartlett, ). While there is a general agreement between these guidelines in terms of evaluation of validation parameters, significant diversity exists with respect to methodology employed.…”

“…Sometimes, the accuracy of LC‐MS/MS determinations, such as in case of tissue bioanalysis, is influenced by different extraction recoveries of analytes from spiked tissue calibration standard and quality control samples (QCs) in comparison with the recovery of same analytes from incurred tissue samples (Yuan et al, ). More details on the evaluation of the main errors that can be encountered during bioanalytical method development/validation and analysis of clinical or preclinical samples as well as the most practical ways for avoiding and managing these hazards during routine applied bioanalysis have been debated in a recent review (Hooshfar & Bartlett, ).…”