HPLC Method for Analysis of Bivalirudin and Asp9 – bivalirudin on BIST A+

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Chromatogram

Description

· HPLC Method for Analysis of Bivalirudin on BIST A+ Column by SIELC Technologies

Bivalirudin is a short, 21-amino-acid peptide with the chemical formula C 98 H 138 N 24 O 33 .  It has 2 basic and 6 acidic groups. It is sold as a direct thrombin inhibitor (DTI), which is used as an anticoagulant.

Asp 9 -bivalirudin is a process impurity and can be a result of the degradation of the drug bivalirudin. It has the chemical formula C 98 H 137 N 23 O 34 .

SIELC’s new BIST™ mode can retain and separate Bivalirudin and its degradant with a TMDAP phosphate buffer, and the respective retention times can be controlled by altering the pH of the buffer.

Method Parameters

Mobile PhaseMeCN – 30%
BufferTMDAP phosphate – 5 mM  pH 5.0, pH 6.0
Flow Rate0.2 mL/min
DetectionUV 275 nm
Class of CompoundsDrugs, Anticoagulant
Analyzing CompoundsBivalirudin

HPLC Column Used

BIST A+, 2.1 x 100 mm, 3 µm, 100 A, dual ended