Unknown Impurity of Sertraline - Formamide?

Confirmatory Testing & Analytical Challenges
21

Hi Carme,

we did not had a chance yet to develop this method internally. However, for a different product, we were able to separate N-formyl and N-nitrosamine by using a standard Waters Sunfire C18 column (Part-No 186002554) applying a gradient with water +0.1% FA (A) and ACN/water + 0.1% FA (95/5, B).
Started with 60/40 A/B, held for 4 minutes, increased to 100% B between 4 and 7 minuntes, held it for 12 minutes, changed back to starting conditions and held until 14 minuntes. This was just for a quick experiment and N-formyl and N-Nitrosamine was baseline separated.

Best regards
Andreas

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22

Hi Andreas,
Thanks a lot for your answer!
Were you working with an APCI source for this other API?
Kind regards,
Carme

23

Hi Carme,

we acutally tried out both ESI+ and APCI+, both ion sources were feasible for that API.

Best regards
Andreas

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