Synthesis and Characterization of Impurities in the Production Process of Lopinavir

Ambati V Raghava Reddy; Srinivas Garaga; Chandiran Takshinamoorthy; Andra Naidu

doi:10.3797/scipharm.1407-14

Synthesis and Characterization of Impurities in the Production Process of Lopinavir

Sci Pharm. 2014 Sep 22;83(1):49-63. doi: 10.3797/scipharm.1407-14. Print 2015 Jan-Mar.

Authors

Ambati V Raghava Reddy¹, Srinivas Garaga², Chandiran Takshinamoorthy³, Andra Naidu⁴

Affiliations

¹ Chemical Research and Development Department, Aurobindo Pharma Ltd, Survey No: 71&72, Indrakaran Village, Sangareddy Mandal, Medak district, Hyderabad-502329, Telangana State, India; Department of Chemistry, Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad, Telangana State, India.
² Chemical Research and Development Department, Aurobindo Pharma Ltd, Survey No: 71&72, Indrakaran Village, Sangareddy Mandal, Medak district, Hyderabad-502329, Telangana State, India; Department of Engineering Chemistry, A. U. College of Engineering (A), Andhra University, Visakhapatnam-530 003, Andhra Pradesh, India.
³ Chemical Research and Development Department, Aurobindo Pharma Ltd, Survey No: 71&72, Indrakaran Village, Sangareddy Mandal, Medak district, Hyderabad-502329, Telangana State, India.
⁴ Department of Chemistry, Jawaharlal Nehru Technological University Hyderabad, Kukatpally, Hyderabad, Telangana State, India.

Abstract

Lopinavir is an antiretroviral drug used for the inhibition of HIV protease. Four related substances of lopinavir were observed during the manufacturing process of lopinavir in the laboratory and they were identified. The present work describes the origin, synthesis, characterization, and control of these related substances.

Keywords: Lopinavir; Related substances; Synthesis and Characterization of impurities.