News
04.03.2022
Ultra-sensitive Nitroglycerin LC-MSMS assay established for support of BE studies
Nitroglycerin, a vasodilator, is used to treat people who have coronary artery disease. It works by relaxing the blood vessels by releasing nitric oxide so the heart does not need to work as hard and therefore does not need as much oxygen. Nitroglycerin is metabolized to 1,2- and 1,3- dinitro-glycerin, which have still pharmacologic activity. The metabolites have the same mass and the same fragment, and so must be chromatographically separated.
We were able to develop and validate a method which have a LLOQ for Nitroglycerin of 25 pg/mL and 10 pg/mL for both metabolites. Baseline separation of the metabolites were achieved in a time frame of less then 9 min. All figures for precision and inaccuracy were in the single digit range with the exception for the LLOQ, where they were slightly above.
With this ultra-sensitive assay, we are well prepared to support coming BE studies and so supporting best our partner during product development. If you have similar needs, feel free to contact us.
Graph shows LLOQ samples overlaid over blank samples
