Chromatography Forum

Hello,

I'm quantifying one active from three different matrix compositions as follows:

Matrix 1: Contains components A and B and the active
Matrix 2: Contains components A, B and C and the active
Matrix 3: Contains components A, B, C and D and the active

am I right saying that I can perform specificity, linearity, accuracy etc. only on matrix 3 and the method will be valid also for matrix 1 and 2?

Another thing; I'll be using 100 ul injection routinely. However rarely I may need to use larger injection volume e.g. for diluted samples. Which validation tests should I repeat for the high volume extension?

thanks

Precision should be carried out for each formulation.
Linearity and recovery can be combined.
Specificty should be handled very carefully. Degradation studies should be performed for individual formulation.
Solution stability-For each formulation.
Robustness can be performed in formulation containing all components.