Chromatography Forum

Dear all
I am developing method for simultaneous estimation of the two antidibetic drugs.
As i develop the method i got retention time for first drug 8.5 min and another drug 11.7min. As there is base line separation for both drugs. As i am developing the stability indicating method for these both drugs. Some of the following problems i am facing.
1. As there enough equilibration of the column but the base stabilization is not there . I am using Ammonium acetate buffer with acetonitrile (55:45%v/v) with C18 (250 x4.6mm) column.
2. Is the separation factor should be consider as regulatory point of view and also as method suitability ?
As separation (alpha) for both drugs is 1.40 . As generally for chiral separation the alpha should be more than 2.0.
I am deliberately waiting for the reply.

Thanking you

PRASHANT

As there enough equilibration of the column but the base stabilization is not there

What problem are you seeing?

Is the separation factor should be consider as regulatory point of view and also as method suitability ?
As separation (alpha) for both drugs is 1.40 . As generally for chiral separation the alpha should be more than 2.0

Resolution would be a better system suitability parameter than alpha. The US FDA suggests (but does not require) that Rs be > 2. For a 10,000-plate separation, this implies an alpha value of about 1.1