A systematic review on chromatography-based method validation for quantification of vancomycin in biological matrices

Abstract

A fully validated bioanalytical methods are prerequisite for pharmacokinetic and bioequivalence studies as well as for therapeutic drug monitoring. Due to high pharmacokinetic variability and narrow therapeutic index, vancomycin requires reliable quantification methods for therapeutic drug monitoring. To identify published chromatographic based bioanalytical methods for vancomycin in current systematic review, PubMed and ScienceDirect databases were searched. The selected records were evaluated against the method validation criteria derived from international guidelines for critical assessment. The major deficiencies were identified in method validation parameters specifically for accuracy, precision and number of calibration and validation standards, which compromised the reliability of the validated bioanalytical methods. The systematic review enacts to adapt the recommended international guidelines for suggested validation parameters to make bioanalysis reliable.