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

2010 ◽  
Vol 78 (3) ◽  
pp. 411-422 ◽  
Author(s):  
Balasekhara Reddy Challa
Keyword(s):  
Human Plasma ◽  
Method Development ◽  
Bioequivalence Study ◽  
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.

BIO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULANEOUS ESTIMATION OF NITAZOXANIDE AND OFLOXACIN IN HUMAN PLASMA BY RP-HPLC

INDIAN DRUGS ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 47-57
Keyword(s):  
Human Plasma ◽  
High Performance ◽  
Method Development ◽  
Reversed Phase ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Liquid Chromatography Method ◽  
Development And Validation ◽  
Lower Limits

An isocratic Reversed-Phase High Performance Liquid Chromatography method has been developed for rapid and simultaneous separation and estimation of two antibiotics, namely, nitazoxanide and ofloxacin, in human plasma. Separation was carried out on Altima C8 (150 x 4.6 mm, 5µ) column using a mobile phase of 0.1% ortho phosphoric acid: acetonitrile (50:50, V/V) at 260 nm. The retention time of nitazoxanide and ofloxacin was noted to be 4.850 and 7.949 min, respectively. The average % recovery for nitazoxanide and ofloxacin were 98.012 % and 94.176 %, respectively and reproducibility was found to be satisfactory. The linearity was investigated in the concentration range of 0.02-2 µg/ml (r2=0.9996) for nitazoxanide and 0.008-0.8 µg/ml (r2=0.9998) for ofloxacin. The lower limits of quantification were 0.0196 µg/ml and 0.0079 µg/ml for nitazoxanide and ofloxacin, respectively, which reach the level of both drugs possibly found in human plasma. The proposed method can be applied for etermination of nitazoxanide and ofloxacin from dosage forms during pharmacokinetic study.

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