Hemolysis of Blood Samples has no Significant Impact on the Results of Pharmacokinetic Data

Purpose: This study examined whether hemolyzed blood samples affect the pharmacokinetic (PK) profile. Methods: A validated LC-MS/MS method was used to analyze both hemolyzed and non-hemolyzed plasma samples obtained from healthy volunteers to whom Clopidogre, Methylprednisolone and Ropinirole were administrated orally in three independent bioequivalence (BE) studies. Results: The drug concentrations of hemolyzed and non-hemolyzed plasma samples, were, respectively: clopidogrel (n=12) 862.57 ± 860.16 (ng/mL) and 920.61 ± 959.14 (ng/mL); Methylprednisolone (n=10) 155.21 ± 33.60 (ng/mL) and 160.01 ± 29.9 (ng/mL); Ropinirole (n=16) 1322.87 ± 392.96 (ng/mL) and 1151.42 ± 299.91 (ng/ mL). The drug concentrations between hemolyzed and non-hemolyzed plasma samples did not yield a significant difference (P>0.05). Conclusions: The measurable plasma concentrations of the test drugs were not significantly different from those of normal non-hemolyzed plasma samples, suggesting that there was no impact on the accuracy of PK profile of the three test drugs.