different peak area in GC
Posted: Tue Aug 29, 2006 7:34 pm
Dear All,
We validated a GC method of a drug substance, containing 6 OVIs, 2 years ago ( by using Trace 2000 GC ). Nowadays, we are testing this drug substance on the same GC, but we can not get same peak area from standart with the validation results for all OVIs, some of them give same peak area but others are about 2 times greater than the validation results.
Can we use this method? or must we revalidate the method? or what can we do else?
Thanks for your hepls in advance.
We validated a GC method of a drug substance, containing 6 OVIs, 2 years ago ( by using Trace 2000 GC ). Nowadays, we are testing this drug substance on the same GC, but we can not get same peak area from standart with the validation results for all OVIs, some of them give same peak area but others are about 2 times greater than the validation results.
Can we use this method? or must we revalidate the method? or what can we do else?
Thanks for your hepls in advance.