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development and validation of stability indicating lc method for olmesartan medoxomil稳定的发展和验证表明lc方法olmesartan medoxomil.pdf

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development and validation of stability indicating lc method for olmesartan medoxomil稳定的发展和验证表明lc方法olmesartan medoxomil

American Journal of Analytical Chemistry , 2012, 3, 153-160 /10.4236/ajac.2012.32022 Published Online February 2012 (http://www.SciRP.org/journal/ajac) Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil 1,2* 1 2 Chimalakonda Kameswara Rao , Kakumani Kishore Kumar , Maddala VijayaLaxmi , 2 2 1 2 Polisetty Srinivasulu , Gutta Madhusudhan , Khagga Mukkanti , Koduri Sai Venkata Srinivas 1Centre for Chemical Sciences, Institute of Science and Technology, Jawaharlal Nehru Technological University, Hyderabad, India 2Analytical Development Laboratory, Inogent Laboratories Private Limited, Hyderabad, India * Email: Kameswararao_scientist@yahoo.co.in Received December 5, 2011; revised January 8, 2012; accepted January 16, 2012 ABSTRACT The present method provides the detailed description of development and validation of a simple stability indicating re- verse phase column liquid chromatographic method for Olmesartan in the presence of its impurities namely Imp-A, Imp-B, Imp-C, Imp-D, Imp-E, Imp-F and Imp-G and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, Oxidative, photolytic and thermal stress degradation. The degradation of Olmesartan was observed under acid hydrolysis, base hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from syn