Abstract: Bivalirudin is a peptide medication derived from natural peptide, Hirudin. One unknown peptide impurity was observed in stability studies sample provided by pharmaceutical company Piramal Pharma Ltd at RRT 0.44. It was purified using open column chromatography and preparative HPLC to 98.03% for chemical characterization. High Resolution Mass Spectrometry based Amino Acid Sequencing was carried out to get amino acid sequence. It has provided sequence of total 18 amino acids as Arginine –Proline – Glycine – Glycine – Glycine – Glycine – Asparagine – Glycine – Aspartic acid – Phenylalanine – Glutamic acid – Glutamic acid – Isoleucin – Proline – Glutamic acid – Glutamic acid – Tyrosine – Leucine........
Keywords: Bivalirudin, COSY, DEPT, HSQC, HMBC.
[1].
Carlos A. Valdes, Sharaf OM, Bleiweis MS, Jacobs JP, Mumtaz M, Sharaf RM, Jeng EI and Peek GJ (2023), Heparin-based versus bivalirudin-based anticoagulation in pediatric extracorporeal membrane oxygenation: A systematic review, Front. Med, 10:1137134
[2].
Vyatkina K., (2022) Validation of De Novo Peptide Sequences with Bottom-Up Tag Convolution, Proteomes 2022, 10, 1, https:// doi.org/10.3390/proteomes10010001
[3].
Jing Li, Sanbao Chen, Sicong Ma, Mingque Yang, Zizhao Qi, Kun Na, Miaohan Qiu, Yi Li, and Yaling Han, (2022), Safety and Efficacy of Bivalirudin versus Unfractionated Heparin Monotherapy in Patients with CAD and DM Undergoing PCI: A Retrospective Observational Study, Cardiovascular Therapeutics, Volume 2022, Article ID 5352087, 10 pages
[4].
Kostromina M.A., Tukhovskaya E.A., Shaykhutdinova E.R., Slashcheva G.A., Ismailova A.M., Palikov V.A., Palikova Y.A., Dyachenko I.A., Kravchenko I.N., Sadovnikova E.S., (2021), Screening of the Promising Direct Thrombin Inhibitors from Haematophagous Organisms. Part I: Recombinant Analogues and Their Antithrombotic Activity In Vitro, Biomedicines 2022, 10, 11
[5].
Alessandra Basso, (2019), Development of a novel combined IEX-RP chromatographic process for the purification of bivalirudin, CHROMATOGRAPHY TODAY, August / September 2019