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Ibrahim Komeil ☆ Egypt, 2019-10-19 04:18 (2044 d 10:32 ago) Posting: # 20704 Views: 5,110 |
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Hello 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 |
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hirenmistri ☆ India, 2019-11-28 11:51 (2004 d 01:59 ago) @ Ibrahim Komeil Posting: # 20882 Views: 3,799 |
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Hi, 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. |
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Ibrahim Komeil ☆ Egypt, 2019-11-28 16:48 (2003 d 21:02 ago) @ hirenmistri Posting: # 20888 Views: 3,729 |
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Hi 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. BR, Ibrahim 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] |
Ing. Helmut Schütz