Simultaneous determination of duloxetine and 4-hydroxy duloxetine glucuronide in human plasma and back-conversion study

Bioanalysis ◽  
2021 ◽  
Author(s):  
Gabriel Onn Kit Loh ◽  
Emily Yii Ling Wong ◽  
Yvonne Tze Fung Tan ◽  
Yi Lin Lee ◽  
Chun Keat Chew ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Human Plasma ◽  
Method Validation ◽  
Bioequivalence Study ◽  
Stability Study ◽  
Bioanalytical Method Validation ◽  
Study Materials ◽  
Study Results ◽  
Back Conversion

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.

Simultaneous Determination of Enalapril and Enalaprilat in Human Plasma by LC-MS: Application to a Bioequivalence Study

2007 ◽  
Vol 65 (3-4) ◽  
pp. 209-215 ◽  
Author(s):  
Ping Wang ◽  
Yi-Zeng Liang ◽  
Ben-Mei Chen ◽  
Neng Zhou ◽  
Lun-Zhao Yi ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Human Plasma ◽  
Bioequivalence Study ◽  
Enalapril And Enalaprilat

Alternative LC–MS–MS Method for Simultaneous Determination of Proguanil, Its Active Metabolite in Human Plasma and Application to a Bioequivalence Study

2009 ◽  
Vol 70 (7-8) ◽  
pp. 1095-1102 ◽  
Author(s):  
Satish G. Pingale ◽  
Ketan K. Nerurkar ◽  
Ajit M. Padgaonkar ◽  
Uttam D. Pawar ◽  
Kiran V. Mangaonkar
Keyword(s):  
Simultaneous Determination ◽  
Human Plasma ◽  
Active Metabolite ◽  
Bioequivalence Study

Sensitive LC-MS/MS-ESI method for simultaneous determination of montelukast and fexofenadine in human plasma: application to a bioequivalence study

2014 ◽  
Vol 28 (8) ◽  
pp. 1048-1056 ◽  
Author(s):  
Rajendraprasad Muppavarapu ◽  
Swati Guttikar ◽  
Manavalan Rajappan ◽  
Kannan Kamarajan ◽  
Ramesh Mullangi
Keyword(s):  
Simultaneous Determination ◽  
Human Plasma ◽  
Bioequivalence Study
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