Quantitative Determination of CKD-516 and Its Metabolite, S-516 in Human Plasma by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

摘要

We established a new validated method for the simultaneous determination of CKD-516 and its active metabolite, S-516 in human plasma. The analytes were validated over the ranges from 0.5 ng/mL to 500 ng/mL for CKD-516 and from 0.2 ng/mL to 200 ng/mL for S-516. The precision and accuracy of QC samples were within +- 15percent in terms of acceptance criteria and were stable during the maximum period (30 hr at 10 deg C, 5 hr at room temperature, freeze and thaw at -70 deg C) of analysis. This sensitive and simple method appears to be useful for the pharmacokinetic analysis of the CKD-516 and S-516.