Analytical method [Bioanalytics]

posted by Cmaxsant – India, 2014-06-20 11:57 (3992 d 11:42 ago) – Posting: # 13099
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Dear Members,

I have one example of bioanalytical method for one Fixed dose combinaion of Two drug A & B, which is having the same extraction (Protein ppt method) method for both the drug.
In recovery study i am getting a trend, Drug A has the recovery (89, 92, 97 for High, med & low concentration), while for Drug B the recovery is (75, 68, 63 for high, mid & low conc.).

I am getting matrix factor in between 0.5 to 0.7. Both Drug is not having any active metabolite, but have metabolites.

Do I need to improve the method or I can go ahead for method validation.

Your view in this regard is appreciable.

Thanks for your answers

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