Journal of Chromatography & Separation Techniques
Open Access
ISSN: 2157-7064
+44 1300 500008
ISSN: 2157-7064
+44 1300 500008
Parastoo Azadi
Posters-Accepted Abstracts: J Chromatogr Sep Tech
Low-molecular weight heparins (LMWH) are used for the treatment of deep venous thrombosis and pulmonary embolism. Lovenox (Enoxaparin sodium) is one of several LMWHs available on the market. This drug does currently not have patent protection and as a result, several generic versions have been produced. As part of the ā??Abbreviated New Drug Applicationā? (ANDA) framework, the FDA published guidelines to clarify what is required to demonstrate sameness of a generic version of Enoxaparin sodium with the innovator product, Lovenox. These guidelines include the requirement to show ā??equivalence of physicochemical propertiesā?. The guidelines suggest the CTA-SAX HPLC method as one method suitable to establish equivalence. In our laboratory we have used Liquid chromatography-mass spectrometry (LC-MS) as an alternative to the CTA-SAX method with several very promising advantages over it, including greater resolution and sensitivity and separation into 5-10 times the number of peaks, as well as the ability to obtain molecular weight information and identify individual components rather than providing a fingerprint only. Regular HPLC requires prohibitively long run times in order to efficiently separate the Enoxaparin oligosaccharides, but ultra-high pressure liquid chromatography (UPLC) shortens the run times to practical values. This new method can be used to quantify the percentage of saturated reducing ends, as well as the percentage of Enoxaparin chains featuring a 1, 6-anhydro structure at the reducing end. The latter quantity is a critical parameter in the characterization and biosimilarity evaluation of generic Enoxaparin samples. This methodology will allow for extremely detailed analysis of a mixture which has not been easily possible up to this point.