e-Bulletin / February 2013
Algorithme Pharma Develops Superior Omega-3 Bioanalytical Methods
When it comes to endogenous free eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total assay of bound EPA and DHA quantification, consideration should be given to multiple key areas. Algorithme Pharma has developed unique analytical methods, leading the industry for the quantification of free EPA/ DHA and total EPA/ DHA
Total EPA and DHA
EPA and DHA are known to demonstrate several different affinities for in-vivo binding resulting in various bound EPA and DHA entities (such as triglycerides, phospholipids, etc). Therefore, truly reliable back-calculation of the total EPA and DHA quantification has to be performed against free EPA and DHA calibration curves after complete hydrolysis to avoid having to use multiple bound EPA and DHA calibrations curves.
Our novel method uses a high efficient hydrolysis to guarantee 100% yield and allow reliable back-calculation of total EPA and DHA concentrations against free EPA and DHA calibration curves. Leveraging our Flash Hydrolysis procedure has resulted in an efficient and reproducible total EPA and DHA method which has been demonstrated to be selective and reliable.
Now Available in Human and Preclinical Matrices
Our total EPA and DHA method has been optimized for human plasma and dog plasma sample analysis. We have ongoing research to optimize the method for rat plasma.
Free EPA and DHA
Due to the presence of bound EPA and DHA entities in incurred samples, the stability evaluations of the free EPA and DHA quality control samples do not mimic incurred samples. In our laboratory, an increase in incurred sample EPA endogenous level was observed over time whereas quality control samples of EPA did not demonstrate the same phenomenon. This increase is believed to come from enzymatic conversion of bound EPA to free EPA.
Algorithme Pharma has developed an innovative technique used during sample collection to avoid bound EPA and DHA degradation. Without this precaution, failure of the incurred sample reproducibility evaluation would be expected.
Dr. Fabio Garofolo, Vice President Bioanalytical Service, will present our novel discoveries and innovative approaches for EPA and DHA bioanalyses to the global bioanalytical community and Regulatory Agencies at the 7th Workshop on Recent Issue in Bioanalysis (7th WRIB) on April 09th, 2013 in Long Beach, California, USA.