A validated LC-MS/MS method for the low-level determination of pemafibrate, a novel SPPARMα, in plasma.

Background: Pemafibrate, a novel selective peroxisome proliferator-activated receptor-α modulator, is prescribed for patients with dyslipidemia. To investigate other potential nonlipid-related effects of pemafibrate, the sensitive and rapid quantitation method for pemafibrate was required. Results: The developed LC-MS/MS assay method exhibited excellent accuracy, precision, sensitivity, stability, no matrix effect and high recovery. The LOQ (0.05 ng/ml) and run time (6.0 min) were superior to previous reports. The calibration curve showed good linearity over the wide concentration range (0.05-100.00 ng/ml). This validated method was successfully applied in a rat pharmacokinetic study using lower doses (0.02 or 0.10 mg/kg) than have been previously reported. Conclusion: This method can support gathering data for the evaluation of pemafibrate in future studies.