Development and full validation of a quantitative assay for the determination of valsartan in human plasma and its application for bioequivalence study

2010 ◽  
Vol 28 (1) ◽  
pp. 7-13 ◽  
Author(s):  
Muzaffar Iqbal ◽  
Khalid A. Al-Rashood
Keyword(s):  
Human Plasma ◽  
Bioequivalence Study ◽  
Quantitative Assay

scholarly journals Validated LC-MS/MS Method for the Determination of Rosuvastatin in Human Plasma: Application to a Bioequivalence Study in Chinese Volunteers

2011 ◽  
Vol 02 (04) ◽  
pp. 341-346 ◽  
Author(s):  
Dujuan Zhang ◽  
Jing Zhang ◽  
Xiaoyan Liu ◽  
Chunmin Wei ◽  
Rui Zhang ◽  
...  
Keyword(s):  
Human Plasma ◽  
Bioequivalence Study

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.

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