Degradation Impurities in Linagliptin Drug Product

Naresh Akkina^a, Bala Narasimha Reddy Gona^a,B. Venkateswara Rao^b, Paul Douglas Sanasi^b, Sukumar Nandi^*a
aDepartment of Chemical Research and Development, Aurobindo Pharma limited., Survey No. 71 & 72, Indrakaran Village, Sangareddy Mandal, Medak District – 502 329, Telangana, India.
^bDepartment of Engineering Chemistry, A.U. College of Engineering, Andhra University, Visakhapatnam-530003, Andhra Pradesh, India.

A B S T R A C T
Three degradation impurities related to Linagliptin (1) drug product, N-Acetyl Linagliptin (2), N-Aminoacyl Linagliptin (3) and N-Formyl Linagliptin (4) have been synthetically prepared and characterized. These impurities form due to interaction of excipient and active pharmaceutical ingredient (API) during formulation. Formation of above drug product degradation impurities has been investigated.
Keywords: Linagliptin, excipient, drug product, degradation, impurities