Terbinafine Nitrosamines

Guidance, Documents, Resources
1

Hi all,
Do you have any methodology of N-Nitroso Desmethyl terbinafine in Terbinafine tablets.
Here we are facing the problem of peak separation of two peak in sample solution. In standard solution single peak was detected.Ther is no problem sample peak.it separation is good
Please suggestions for separation in sample solution
Thank you

2

Hi Siva
Could you share more information so we would be able to help?

M phase composition
Diluent
Column used

Thank you!!

3

Just for context, here are few details of the method that we are trying…

Mobile Phase-A: 0.1% Formic acid in water-A
Mobile phase-B:100% Methanol.
We also tried in Ammonium formate,Ammonium acetate,TFA as mobile phase-A and 100% ACN,combination of ACN: Methanol as mobile phase-B.
Diluent:ACN:Water(1:1) and Methaol:Water(1:1) two diluents were used
C18,phenyl and CN are used.
Present Supleco Discovery CN was used

Any help or suggestion is welcome!

4

I know that Terbinafine solubility in water is not good, so unfortunately we need to increase Methanol to dissolve.
_ What is your Initial M phase %.

  • Does the peaks of Terb. and N-Nitroso elute too early together?

I would try Phenyl Hexyl column to get more Retension.