scholarly journals Method Development and Validation of Olprinone in Human Plasma by HPLC Coupled with ESI-MS-MS: Application to a Pharmacokinetic Study

2013 ◽  
Vol 52 (5) ◽  
pp. 400-405 ◽  
Author(s):  
Hongbo Wang ◽  
Baochang Zhang ◽  
Xilin Sun ◽  
Yantong Sun ◽  
Meiyun Shi
Author(s):  
Dibya Das ◽  
Dhiman Halder ◽  
Himangshu Sekhar Maji ◽  
Pintu Kumar De ◽  
Sudipta Saha ◽  
...  

The aim of the present work is to develop and validate an accurate, sensitive, rapid, precise, and simple bioanalytical method for estimation of Febuxostat in human plasma by using LC-ESI-MS/MS. The method was developed by gradient elution technique with the combination of the mobile phase as 0.1% Formic Acid in Milli-Q water and 0.1% Formic Acid in Acetonitrile at a flow rate of 0.5ml/min. The Analyte and IS (Tolbutamide) were separated by a C18 Phenomenex Kinetex (50x3mm, 5µ) column. The chromatographic run time was 7.0 minutes. The plasma extraction was done by a simple protein precipitation technique (PPT). The LOD and LLOQ were found to be 6.25ng/ml and 125ng/ml, respectively. The extraction recovery of the drug from plasma was more than 90%. The validation parameters were found within the range, as mentioned by USFDA and EMA guidelines.


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