Development and validation a LC–MS/MS method for the simultaneous determination of agomelatine and its metabolites, 7-desmethyl-agomelatine and 3-hydroxy-agomelatine in human plasma: Application to a bioequivalence study

2015 ◽  
Vol 1003 ◽  
pp. 60-66 ◽  
Author(s):  
Meizhen Li ◽  
Fang Tang ◽  
Feifan Xie ◽  
Yisha Lv ◽  
Peng Yu ◽  
...  
Bioanalysis ◽  
2021 ◽  
Author(s):  
Gabriel Onn Kit Loh ◽  
Emily Yii Ling Wong ◽  
Yvonne Tze Fung Tan ◽  
Yi Lin Lee ◽  
Chun Keat Chew ◽  
...  

Aim: To develop an LC-MS/MS method for simultaneous determination of duloxetine and its metabolite, 4-hydroxy duloxetine glucuronide (4HDG) in human plasma and to investigate the potential back-conversion of 4HDG to duloxetine using stability study. Materials & methods: The LC-MS/MS method was validated according to the EMA and USFDA Bioanalytical Method Validation Guidelines and applied to pilot bioequivalence study. Results & conclusion: The method validation results were within the acceptance limits. The stability study and incurred sample reanalysis results ruled out the occurrence of back-conversion. The study highlighted the conduct of back-conversion test and the advantages of LC-MS/MS method in terms of sensitivity, specificity and low consumption of organic solvents.


Talanta ◽  
2020 ◽  
Vol 206 ◽  
pp. 120193 ◽  
Author(s):  
Beatriz Arce-López ◽  
Elena Lizarraga ◽  
Myra Flores-Flores ◽  
Ángel Irigoyen ◽  
Elena González-Peñas

2006 ◽  
Vol 830 (2) ◽  
pp. 207-211 ◽  
Author(s):  
Mohammad-Reza Rouini ◽  
Yalda Hosseinzadeh Ardakani ◽  
Faezeh Soltani ◽  
Hassan Y. Aboul-Enein ◽  
Alireza Foroumadi

2007 ◽  
Vol 65 (3-4) ◽  
pp. 209-215 ◽  
Author(s):  
Ping Wang ◽  
Yi-Zeng Liang ◽  
Ben-Mei Chen ◽  
Neng Zhou ◽  
Lun-Zhao Yi ◽  
...  

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