ESI-MS/MS stability-indicating bioanalytical method development and validation for simultaneous estimation of donepezil, 5-desmethyl donepezil and 6-desmethyl donepezil in human plasma

2011 ◽  
Vol 26 (5) ◽  
pp. 636-649 ◽  
Author(s):  
Arshad H. Khuroo ◽  
Sanjay J. Gurule ◽  
Tausif Monif ◽  
Dipanjan Goswami ◽  
Arabinda Saha ◽  
...  
Keyword(s):  
Human Plasma ◽  
Method Development ◽  
Simultaneous Estimation ◽  
Bioanalytical Method ◽  
Stability Indicating ◽  
Esi Ms ◽  
Method Development And Validation ◽  
Development And Validation

Introduction of an Innovative approach for Bioanalytical Method Development and Validation of Febuxostat by using LC-ESI-MS/MS in Human Plasma

2021 ◽  
pp. 4060-4066
Author(s):  
Dibya Das ◽  
Dhiman Halder ◽  
Himangshu Sekhar Maji ◽  
Pintu Kumar De ◽  
Sudipta Saha ◽  
...  
Keyword(s):  
Formic Acid ◽  
Human Plasma ◽  
Method Development ◽  
Gradient Elution ◽  
Bioanalytical Method ◽  
Esi Ms ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Plasma Extraction

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.

Bioanalytical Method Development and Validation of Doravirine, Lamavudine and Tenofovir Disoproxil Fumarate using HPLC in Human Plasma

2021 ◽  
pp. 4087-4091
Author(s):  
Marakatham S. ◽  
Shanmugapandiyan P.
Keyword(s):  
Human Plasma ◽  
Tenofovir Disoproxil Fumarate ◽  
Method Development ◽  
Potassium Dihydrogen Phosphate ◽  
Internal Standard ◽  
Stability Study ◽  
Dihydrogen Phosphate ◽  
Bioanalytical Method ◽  
Method Development And Validation ◽  
Development And Validation

A novel, simple and sensitive bioanalytical method was developed for estimation of Doravirine, Lamavudine and tenofovir disoproxil fumarate in human plasma with daclatasvir as internal standard. The method was developed using alliance HPLC using Phenomenex C18 (150mm x 4.6mm, 5m) column with mobile phase of 0.01N Potassium dihydrogen phosphate pH (3.5): Acetonitrile (60:40) at flow rate of 1.0ml/min. Detection wavelength was found to be 277nm. The linearity range for doravirine, lamuvidine and Tenfovir was 50-2000ng/ml, 125-5000ng/ml and 20-800ng/ml. Correlation coefficient was 0.999. The method was validated and stability study was carried out as per FDA guidelines.

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