Abstract
Olmesartan medoxomil(1)is the latest angiotensin receptor antagonist approved by the FDA for the treatment of hypertension. During the process development of olmesartan medoxomil, three process-related impurities were observed along with the final API. These impurities were identified as isopropyl olmesartan (12), dimedoxomil olmesartan (19), dibiphenyl olmesartan (17). The present work describes the synthesis and characterization of all these three impurities.
Highlights
Drugs have become an important part of human life to combat various deceases
During the process for the synthesis of (1), olmesartan medoxomil has been prepared by the following synthetic route [4, 7] described in Scheme 1
Two known impurities (7 and 8) were detected in HPLC of compound 1 (Figure 2), and besides, of these, three unknown impurities were observed during the process development exercise for the preparation of olmesartan medoxomil following Scheme 1
Summary
Drugs have become an important part of human life to combat various deceases. Unlike ancient days, most of the drugs in recent years are purely synthetically made. The synthetic drugs certainly contain various impurities such as either chemical or microbial. Most of the impurities are chemical only. E impurity levels in any drug substance are described as per its biological or toxicological data. It is quite important for “regulatory” aspect of drug approval to provide limitation of “related impurities.” erefore, it is necessary to study the impurity pro le of any API and control it during the manufacturing of a drug product. During the process for the synthesis of (1), olmesartan medoxomil has been prepared by the following synthetic route [4, 7] described in Scheme 1
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