A novel solid phase extraction sample preparation method for sensitively determining doxepin and N-nordoxepin in human plasma and its application in a bioequivalence study in healthy Chinese volunteers

Author:

Zheng Binjie123ORCID,Chen Lulu456,Zheng Tiandong45,Hou Liping4,Huang Xinyi123,Li Chao45,Wang Xintong45,Fang Qing45,Chen Jie45,Tang Zhi45,Li Zhenyu7,Ouyang Dongsheng1234

Affiliation:

1. Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 87 Xiangya Road, Changsha 410008, P. R. China

2. Institute of Clinical Pharmacology, Central South University, Hunan Key Laboratory of Pharmacogenetics, 110 Xiangya Road, Changsha 410078, P. R. China

3. Engineering Research Center of Applied Technology of Pharmacogenomics, Ministry of Education, 110 Xiangya Road, Changsha 410078, P. R. China

4. Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples, Changsha Duxact Biotech Co., Ltd, Changsha, China

5. Hunan Changsha Duxact Clinical Laboratory Co., Ltd, Changsha Duxact Biotech Co., Ltd, Changsha, China

6. School of Pharmacy, Xiangnan University, Chenzhou 423000, China

7. Department of Geriatric Medicine, Xiangya Hospital, Central South University, Changsha, China

Abstract

The proposed method not only greatly reduced the complexity of the extraction section, but it was successfully applied to a bioequivalence study of 3 mg of doxepin tablet formulation in 28 healthy Chinese volunteers under fasting and fed conditions.

Funder

National Natural Science Foundation of China

Key Research and Development Program of Hunan Province of China

Natural Science Foundation of Hunan Province

Science and Technology Program of Hunan Province

Changsha Science and Technology Project

Central South University

Publisher

Royal Society of Chemistry (RSC)

Subject

General Engineering,General Chemical Engineering,Analytical Chemistry

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