采用TSQ Vantage进行大鼠血浆中帕罗西汀的生物分析
前言：
In May 2001, the FDA promulgated its first official guidance for bioanalytical methods.1 This document is titled Guidance for Industry Bioanalytical Method Validation, and serves as a guide for bioanalytical methods supporting clinical and non-clinical studies.Recently, the reproducibility and accuracy of the concentration determined in incurred samples was subject of significant debate, outlined in the American Association of Pharmaceutical Scientists (AAPS) journal paper titled Workshop/Conference Report – Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays.2 Recommendations were put forth to randomly re-assay a subset of previously assayed incurred samples and compare them to the original value to ensure reproducibility and accuracy. Significant deviation (>15-20%) from the original measurement would then require re-evaluation of the bioanalytical method.
The availability of a sensitive and reproducible validated bioanalytical method is a prerequisite for the generation of reliable data on pharmacokinetics (PK), bioavailability, and bioequivalence of drugs. Method validation demonstrates that a bioanalytical method will successfully meet the minimum standards recommended by the Guidance for Industry Bioanalytical Method Validation as it pertains to accuracy, precision, selectivity, sensitivity, reproducibility, and stability. However, after repeated exposure to biological matrices, ensuring precision and accuracy at the lower limit of quantitation (LLOQ) of a validated bioanalytical method is a challenge faced by every bioanalytical laboratory.
仪器：
结论：
Reproducibility is important because it predicates reliability or the ability of the method to yield similar concentration for a sample when measured on different occasions.4 This is of particular importance to the summary guidance issued at the recent AAPS/FDA Crystal City meeting which requires demonstrating reproducibility of incurred samples. It also means longer time between preventive maintenance cycles, which means higher productivity. The data shown in this article clearly demonstrates the superior reproducibility performance of the TSQ Vantage for high sensitivity LC-MS/MS.
