UPLC-CAD Unknown Dimer RRF Determination

Looking to determine the relative response factor (RRF) for an unknown Naloxone dimer present in our product using and HPLC-UV-CAD (Charged Aerosol Detector) tandem method. We need a USA lab/testing facility with UPLC-CAD to perform this project.

In short, we have developed a UPLC method for the separation and quantitation of Buprenorphine and Naloxone related impurities in Buprenorphine/Naloxone sublingual films. In developing this method, we identified an unknown Naloxone Dimer (ascertained via MS). The Naloxone dimer is present as two isomers (internally identified as Nal Dimer-1/Isomer 1 and Nal Dimer-2/Isomer 2). It is not possible to acquire authentic pure samples of this Naloxone dimer and we can’t determine the RRF by traditional means. We have identified an alternative RRF determination procedure using tandem UV-CAD detectors that do not require an authentic standard.