alexa Hemolysis of Blood Samples has no Significant Impact on the Results of Pharmacokinetic Data | OMICS International | Abstract
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
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Research Article

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

Jie Zhao1, Quancheng Kan1, Jianguo Wen1, Yidong Li1, Yunqiao Sheng1, Li Yang1, Jason Wu2 and Shengjun Zhang1*

1Zhengzhou University First Affiliated Hospital, 1 E. Jianshe Road, Zhengzhou, Henan 450052, P.R. China

2Frontage Clinical Services, 224 Valley Creek Blvd. Suite 300, Exton, PA 19341, USA

*Corresponding Author:
Shengjun Zhang
Zhengzhou University First Affiliated Hospital
1 E. Jianshe Road, Zhengzhou
Henan 450052. P. R. China
Tel: 011-86- 371-66295229
Fax: 011-86-371-6629523
E-mail: [email protected]

Received Date: June 04, 2012; Accepted Date: July 23, 2012; Published Date: July 26, 2012

Citation: Zhao J, Kan Q, Wen J, Li Y, Sheng Y, et al. (2012) Hemolysis of Blood Samples has no Significant Impact on the Results of Pharmacokinetic Data. J Bioequiv Availab 4: 082-085. doi: 10.4172/jbb.1000117

Copyright: © 2012 Zhao J, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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.

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