Ibrahim Komeil

2019-10-19 02:18

Posting: # 20704
Views: 1,413

 Metformin and linaglibtin film coated tablet [Bioanalytics]


I am testing the bio equivalency between two products containing metformin 500 mg and linaglibtin 2.5 mg film coated tablet. my question is about bio-analysis of linaglibtin.

The validation method start the LLOQ of linaglibtin by 1ng/ml but i can't find any good results in test samples. So anyone have a previous experience with bio-analysis of linaglibtin.

Thanks in advance

2019-11-28 10:51

@ Ibrahim Komeil
Posting: # 20882
Views: 803

 Metformin and linaglibtin film coated tablet

I have done bioanalysis of so many studies of metformin and linagliptin. I have not observed such issues.
There is no problem with stability of linagliptin in samples.

Our LLOQ is 0.1 ng/mL for 2.5 mg dose.

Time point selection is also playing role in getting adequate results.
Ibrahim Komeil

2019-11-28 15:48

@ hirenmistri
Posting: # 20888
Views: 786

 Metformin and linaglibtin film coated tablet


Thank you for your kind reply

Actually i face a problem in the bioanalysis for linaglibtin tablets, i optimized the LLOQ for Linaglibtin to 25 pg/ml and still i see low Cmax reaching 0.7 ng/ml. Additionally the terminal elimination phase is too low knowing that linaglibtin half life is approximately 100 hours while it appeared to be about 24 hours in my analysis

So i doubt about the method of linaglibtin extraction from plasma, so can you tell me which method did you use in sample preparation i think there is an issue here.



Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
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