PMID- 37820472
OWN - NLM
STAT- MEDLINE
DCOM- 20231103
LR  - 20231103
IS  - 1873-376X (Electronic)
IS  - 1570-0232 (Linking)
VI  - 1229
DP  - 2023 Sep 1
TI  - Determination of tamsulosin in plasma of healthy Chinese male subjects by a novel 
      and simple LC-MS/MS method and its application to pharmacokinetic studies.
PG  - 123901
LID - S1570-0232(23)00311-2 [pii]
LID - 10.1016/j.jchromb.2023.123901 [doi]
AB  - Tamsulosin, the first highly selective alpha(1)-adrenoceptor antagonist, is widely 
      used for urination disorders caused by benign prostatic hyperplasia (BPH). The 
      pharmacokinetics and safety of 0.2 mg tamsulosin hydrochloride sustained-release 
      capsules were evaluated in 60 healthy Chinese male subjects under fasting and fed 
      conditions in this study. A simple, sensitive, and robust liquid 
      chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and 
      validated for the quantification of tamsulosin in human plasma, which has been 
      applied to pharmacokinetic study. The analyte and internal standard 
      (tamsulosin-d5) were extracted by protein precipitation, and separated on a 
      ZORBAX Eclipse XDB-C18 column (4.6 x 50 mm,1.8 microm; Agilent Tech) using a gradient 
      elution with mobile phases methanol and 5 mM ammonium acetate. The linear range 
      was 0.05-15.0 ng/mL. It showed good selectivity in normal, hyperlipidemic, and 
      hemolyzed blank matrices. The CV (%) of intra-batch precision was <4.4% and the 
      RE (%) of accuracy was in the range of -5.0%-6.7%; the CV (%) of inter-batch 
      precision was <-5.8% and the RE (%) of accuracy was in the range of 1.2%-4.0%. 
      The mean extraction recovery for the analyte was 102.1 +/- 3.75% and for the IS was 
      102.2 +/- 2.00%. Two formulations were considered bioequivalent under fasting and 
      fed conditions, and the 90% confidence intervals for the geometric mean 
      test/reference ratios were within the predetermined range of 80%-125%. A single 
      oral dose of 0.2 mg tamsulosin hydrochloride sustained-release capsule was 
      well-tolerated throughout the clinical trial, and no > Grade 1 adverse events 
      (AEs) and serious AEs occurred during the trial.
CI  - Copyright (c) 2023 Elsevier B.V. All rights reserved.
FAU - Zhong, Maolian
AU  - Zhong M
AD  - School of Pharmacy, Nanchang University, Nanchang 330006, China.
FAU - Wang, Xing
AU  - Wang X
AD  - School of Pharmacy, Nanchang University, Nanchang 330006, China.
FAU - Xiong, Wenqiang
AU  - Xiong W
AD  - School of Pharmacy, Nanchang University, Nanchang 330006, China.
FAU - Liu, Yan
AU  - Liu Y
AD  - School of Pharmacy, Nanchang University, Nanchang 330006, China.
FAU - Wang, Xiaosong
AU  - Wang X
AD  - Clinical Medicine Research Center, Jiangxi Cancer Hospital, Jiangxi Cancer 
      Hospital of Nanchang University, Nanchang 330029, China.
FAU - Yi, Xiaoyi
AU  - Yi X
AD  - Clinical Medicine Research Center, Jiangxi Cancer Hospital, Jiangxi Cancer 
      Hospital of Nanchang University, Nanchang 330029, China.
FAU - Zhang, Hong
AU  - Zhang H
AD  - Clinical Medicine Research Center, Jiangxi Cancer Hospital, Jiangxi Cancer 
      Hospital of Nanchang University, Nanchang 330029, China; Jiangxi Clinical 
      Research Center for Cancer, Nanchang 330029, China. Electronic address: 
      ZLhospital@163.com.
LA  - eng
PT  - Equivalence Trial
PT  - Journal Article
DEP - 20231004
PL  - Netherlands
TA  - J Chromatogr B Analyt Technol Biomed Life Sci
JT  - Journal of chromatography. B, Analytical technologies in the biomedical and life 
      sciences
JID - 101139554
RN  - 0 (Capsules)
RN  - 0 (Delayed-Action Preparations)
RN  - G3P28OML5I (Tamsulosin)
SB  - IM
MH  - Humans
MH  - Male
MH  - Capsules
MH  - Chromatography, Liquid
MH  - Delayed-Action Preparations
MH  - *East Asian People
MH  - Reproducibility of Results
MH  - *Tamsulosin/pharmacokinetics
MH  - Tandem Mass Spectrometry
OTO - NOTNLM
OT  - LC-MS/MS
OT  - Pharmacokinetics
OT  - Protein precipitation method
OT  - Safety
OT  - Tamsulosin
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2023/10/12 00:43
MHDA- 2023/11/03 06:44
CRDT- 2023/10/11 18:05
PHST- 2023/08/15 00:00 [received]
PHST- 2023/09/17 00:00 [revised]
PHST- 2023/10/02 00:00 [accepted]
PHST- 2023/11/03 06:44 [medline]
PHST- 2023/10/12 00:43 [pubmed]
PHST- 2023/10/11 18:05 [entrez]
AID - S1570-0232(23)00311-2 [pii]
AID - 10.1016/j.jchromb.2023.123901 [doi]
PST - ppublish
SO  - J Chromatogr B Analyt Technol Biomed Life Sci. 2023 Sep 1;1229:123901. doi: 
      10.1016/j.jchromb.2023.123901. Epub 2023 Oct 4.