Bioequivalence and Bioavailability Forum 14:24 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

gialuu
Junior

Vietnam,
2018-08-30 10:55

Posting: # 19200
Views: 459
 

 Determination of Indapamide concentration in plasma or whole blood? [Bioanalytics]

Dear Admin and dear all,

I have one problem like below:

- Following many literatures, Indapamide binds mainly to red blood cell (80%).
So that, determination of its concentration in plasma is suitable or not?
Acctually, hemolysis can affect the analytical results if this method is applied.

Give me some recommendations about this problem.

Thanks so much!
Beholder
Regular

Russia,
2018-08-31 14:46

@ gialuu
Posting: # 19202
Views: 361
 

 Determination of Indapamide concentration in plasma or whole blood?

Dear gialuu!

I think you answered your question by yourself.;-)

Best regards
Beholder
Ladi
Junior

Thailand,
2018-09-04 04:00

@ gialuu
Posting: # 19233
Views: 276
 

 Determination of Indapamide concentration in plasma or whole blood?

Dear Gialuu,

According to this FDA Draft Guidance on Indapamide, it should be measured in whole blood.

Regards,
Ladi
gialuu
Junior

Vietnam,
2018-09-06 04:12
(edited by Ohlbe on 2018-09-06 10:26)

@ Ladi
Posting: # 19240
Views: 241
 

 Determination of Indapamide concentration in plasma or whole blood?

Thank you for your information.

Some analytical method developed in plasma matrix were published. And according to those references, they were also applied for BE studies. This makes me confused.

In the case that we have developed an analytical method for determination of Indapamide concentration in plasma and validated the method following FDA Guidelines for some criteria (specificity, sensitivity, accuracy- precision, linearity range, dilution integrity, carry over, matrix effect, stability…) like the others in which the analytes do not bind highly to red blood cells, is there any other addition criterion which has to be validated?

And please share with us some recommendations or some remarkable things while developing an analytical method in whole blood.

Thanks all!


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! [Ohlbe]
Ladi
Junior

Thailand,
2018-09-06 12:38

@ gialuu
Posting: # 19247
Views: 221
 

 Determination of Indapamide concentration in plasma or whole blood?

Dear Gialuu,

I only have done one whole blood project.
  • I remember telling the sample collection team to invert each vacutainer tube 3-5 times immediately before transferring blood samples to cryo-tubes. I observed that when fresh blood samples tubes are kept sitting in the rack for 5-10 min, blood cell sediment (not clotting) and we start seeing two layers.
  • It was hard to visually grade blood samples for lipemia.
  • I was also not sure if I should use fresh or frozen whole blood for freshly samples preparation so I tested during method development and didn't see any differences. But it may vary from molecule to molecule.

Regards,
Pratheep
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum |  Admin contact
18,700 posts in 3,984 threads, 1,243 registered users;
online 15 (0 registered, 15 guests [including 9 identified bots]).

I suppose it is tempting, if the only tool you have is a hammer,
to treat everything as if it were a nail.    Abraham Maslow

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed