Case Study 1
Summary of the Bioequivalence study of the drug Clonidine Hydrochloride USP
0.3 mg Tablets
View Document
Case Study 2
The Challenge:
A rapid and sensitive liquid chromatography –mass spectrometric (LC-MS-MS) method for the determination of Bromocriptine in human plasma using Imipramine as internal standard has been developed and validated.
The Solution:
Sample preparation of plasma involved solid phase extraction using Waters Oasis HLB 60mg/3mL cartridges. Detection was performed using an Applied Biosystems Sciex API 4000 Mass Spectrometer. The assay of Bromocriptine was linear over the range 10 pg/mL to 500pg/mL. The limit of quantification was
10 pg/mL. The method was successfully applied to the Bioequivalence study of tablet of Bromocriptine (2x2.5 mg) administered as a single oral dose.
Case Study 3
The Challenge:
Simultaneous determination of Metformin and Glipizide in human plasma by liquid chromatography electrospray mass spectrometry.
The Solution:
A rapid and sensitive liquid chromatography-mass spectrometric (LC/MS/MS) method was developed & validated using Glimeperide as an internal standard. Detection was performed using an Applied Biosystems Sciex API 2000 mass spectrometer.
The method has a short run time of 5 mins and involves simple sample peparation with acidification with hydrochloric acid and deproteination with acetonitrile. This enables analysis of high number of samples at a time.
