babun
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2009-08-21 16:28
(6157 d 04:23 ago)

Posting: # 4088
Views: 3,782
 

 Change of salt form [Bioanalytics]

Dear Members,

If clinical study has been performed with HCl salt of any analyte then can we prepare the calibration curve and quality control samples with sulfate form or free form of the same analyte ?

I mean if bioequivalence to be proved for metformin sulfate then can metformin hydrochloride be used for method validation ?

Regards,

bani
Helmut
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2009-08-21 17:19
(6157 d 03:31 ago)

@ babun
Posting: # 4090
Views: 3,075
 

 only base/acid important

Dear Bani,

short answer: yes.
BTW concentrations for a BE study should always reported for the free base (or acid) - never the salt, in order to ease comparison between studies (e.g., the literature). Active in the body is always the free form, never any salt.

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babun
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2009-08-24 08:31
(6154 d 12:20 ago)

@ Helmut
Posting: # 4100
Views: 3,072
 

 only base/acid important

Dear HS,

Thanks for the reply. Yes it is only the free analyte which we are quantifying, however for long term stability of bulk spiked sample is there any effect of different salt form in plasma ?

Please correct me if I am not right.


Regards

Bani
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