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Do you have some suggests for Tadalafil impurities in USP ?

http://www.chromforum.org/viewtopic.php?t=79024

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Do you have some suggests for Tadalafil impurities in USP ?

Posted: Wed Nov 29, 2017 9:03 am
by s544186414
I'm following the procedure of USP about the Tadalafil organic impurities.
In the below control and situation:
Mode : LC
Wavelength : 285 nm
Flow rate : 1.0 mL/min
Injection volume : 20 micro-liter
Column : 4.6-mm X 25-cm; 5-micrometer packing L7

I don't know which peak is we-wanted.
Do you have any suggest or spectrum for me to referring?
Thanks.

Re: Do you have some suggests for Tadalafil impurities in USP ?

Posted: Wed Nov 29, 2017 7:47 pm
by dap
Hello.
I wish USP & EP both provide harmonized monographs: https://extranet.edqm.eu/4DLink1/pdfs/c ... s/2606.pdf
I made a year ago raw material QC according to EP so spectra are also available if sill required.

Re: Do you have some suggests for Tadalafil impurities in USP ?

Posted: Sun Dec 10, 2017 2:43 pm
by hossam kamal
[Note— The relative retention times for tadalafil and the 6R ,12aS diastereomer of tadalafil are about 1.0 and 1.03, respectively. ]

from this i think tadalafil peak is the first peak and it diasteriomer is the second

Re: Do you have some suggests for Tadalafil impurities in USP ?

Posted: Sun Dec 10, 2017 3:44 pm
by HPLC chemist
Not very good chromatography. Capacity factor should be at least 2. What are your chromatographic condition? Do you have a resolution requirement in your system suitability acceptance criteria?
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