Anapharm Europe validates new LC/MS/MS bioanalytical method for Tiotropium
Anapharm Europe has successfully developed and validated a bioanalytical method for determination of Tiotropium in human plasma by LC/MS/MS. This method with a Limit of Quantification as low as 0.5 pg/mL adds to the list of high sensitivity methods for inhalers, including Fluticasone and Salmeterol.
Challenges in the Detection of Metabolic Biomarkers Using a Multi Plex Assay
A 5 Plex method for the detection of metabolic biomarkers in human plasma was developed using the U-PLEX technology on the MSD platform.
The complexities surrounding this method were the establishment of endogenous QCs for each chosen biomarker and evaluating the potential use and need for buffer QCs vs matrix QCs where applicable. Additional challenges were faced while trying to ascertain a single minimum required dilution to enable accurate quantification of all biomarkers simultaneously, encompassing the different detection ranges and limits for each biomarker.READ MORE
Considerations to properly assess drug stability within biological samples
Assessing drug stability during method development and validation is of paramount importance. The concentration of the target analyte must remain unaffected throughout the lifecycle of the samples to ensure the reliability of the assay data. However, a decrease in analyte concentration in a biological fluid is not always due to a lack of stability.READ MORE
Challenges in development of robust analytical methods for the quantitation of low molecular weight compounds by LC-MS/MS
Method development can be considered one of the most challenging task in a Bioanalytical laboratory. When working with LC-MS/MS and low molecular weight drugs, low degree of ionization, poor fragmentation, higher presence of isobaric compounds or analyte loss due to their high volatility can get in the way of a successful method development.READ MORE