Quantification of S-amlodipine [PK / PD]

posted by Helmut Homepage – Vienna, Austria, 2016-06-08 03:32 (3169 d 20:51 ago) – Posting: # 16412
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Hi Mauricio,

I incorrectly assumed that you have a chiral method. Sorry.

❝ What are the guaranties of my correct quantification of S-Amlodipine in plasma with a method that do not make any difference between R and S enantiomeres present in analitical reference standard?


There are none. In our case the enantiomeric ratio of the 'racemate' was in fact not 1:1 (checked by MS-MS response and circulardichroism after heart-cut of the eluted peaks). Do you have the study samples already in the fridge without a validated method method? If yes (bad) I would immediately order the certified l-enantiomer. Validate the method with the racemate but state in the protocol that you will correct all concentrations once you have the l-enantiomer. Analyze the study samples with the racemate standards / QCs. This is a last resort - better than to wait for the enantiomer standard and risk that the samples degrade in the meantime. Avoid it in the future.

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