I am trying to develope and validate a GC purity method, but I don't have any knowledge about GC purity test. I have only experience to analyse residual solvents in pharmaceutical material.
I'd like to make GC purity method of liquid pharmaceutical material using capillary column and split mode.
I want to know...
- What concentration of analyte is acceptable..
Can I make the method like as LC purity method? In LC method, I made two sample solutions with different concentration. One is about 1000 ppm, and the other is 1 ppm. And I only validated in the range of lower concentration.In GC purity method, I want to use just one concentration. Could you tell me which concentration is acceptable? And is it OK if I set the linearity range as 50%~150% of the determined concentration?
Also how can I perform the accuracy and precision test?
Anyone who has experienced this GC purity method validation?
By Anonymous on Tuesday, February 18, 2003 - 11:45 pm:
Why anyone doesn't solve this problem?
By Anonymous on Tuesday, June 8, 2004 - 03:41 am:
If you want to perform GC purity by injecting
only one concentration you should do so by
injecting a solution fo such a concentration so
as to get the compound peak in the scale.
This can be achieved by setting sensitivity,
range, split ratio, attenuation collectively so as
to get the peak of interest about 75 to 90% of