bupropion hcL

[nitish]

we use USP refer method for bupropion hcl method for RS . inwhich we use triflouroacetic acid in mobile phase a&b what is the need of TFA for mobile phase simply what role play tfa in our separation

[amaryl]

we use USP refer method for bupropion hcl method for RS . inwhich we use triflouroacetic acid in mobile phase a&b what is the need of TFA for mobile phase simply what role play tfa in our separation

TFA must be added as ion-pairing reagent to overcome peak tailing. Tailing factor should be less then 2 (system suitability parameters).

Regards,

Amaryl.

[jitender]

@nitish: in September 2005 when I joined this forum there was a lot of discussion on use of TFA. You shall search and find the same.

@amaryl- May I get the reference stating tailing factor should be less than 2 ?

[Uwe Neue]

Most USP methods have a limit on the tailing factor. It is commonly 2. Note that there are different ways to measure the peak tailing, and the USP prescribes a very specific one.

[amaryl]

@nitish: in September 2005 when I joined this forum there was a lot of discussion on use of TFA. You shall search and find the same.

@amaryl- May I get the reference stating tailing factor should be less than 2 ?

Here is this nice article on validation...
Shabir G A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J Chromatogr A. 2003;987:57-66.

Check this out even ...
Dolan JW. Why do Peaks Tail?. LCGC North America. 2003 July;21(7):612-16.

Even the book by Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC Method Development. 2nd ed. New York: Wiley-Interscience; 1997.


Regards,

Amaryl.