Monitoring Internal Standard Response Difference between Known and Unknown Samples with LC-MS/MS Based Method for Detecting Matrix-Induced Systematic Error

摘要

1. The matrix-induced systematic error can not always be effectively detected by QC and ISR results during preclinical and clinical studies. 2. Monitoring IS variability, especially the IS response difference between known and unknown samples is necessary and the significant matrix difference between known and unknown samples can be effectively detected. 3. A selected IS may track an analyte very well in controlling random error such as induced during analytical process, but may not be able to correct matrix-induced systematical error. 4. Our results confirmed general opinion: the IS response variability data can not be used as criteria for accepting batch or rejecting batch, but is valuable for triggering investigation. 5. It will be a concern when an LC-MS/MS based method is lacking IS or shows significant retention difference between IS and analyte.