HPLC sample preparation for SR, MR or CR tablets
Posted: Mon Apr 14, 2014 9:59 am
I am having a problem in deciding the diluent for Related substances.
My Assay diluent contains Water:ACN:MeOH::20:40:40, pH 3.0 with OPA in which recovery is 100%.
The RS method earlier developed contains ACN:MeOH::50:50.
The problem with the RS diluent is that it doesn't give the 100 % recovery in case of Assay.
Can I go ahead with ACN:MeOH::50:50 diluent.
Is it mandatory to have RS method having 100% recovery for drug Substance?
My Assay diluent contains Water:ACN:MeOH::20:40:40, pH 3.0 with OPA in which recovery is 100%.
The RS method earlier developed contains ACN:MeOH::50:50.
The problem with the RS diluent is that it doesn't give the 100 % recovery in case of Assay.
Can I go ahead with ACN:MeOH::50:50 diluent.
Is it mandatory to have RS method having 100% recovery for drug Substance?