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Method Development and Validation and Degradation Studies for Cinacalcet Hcl Drug by RP-HPLC Method

Eswara Rao Bammidi*1, Vaikuntarao Lakinani1, David Krupadanam Gazula Levi2
1Departmernt of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatnam, A.P., India
2Department of Chemistry, Osmania University, Hyderabad.
Received: 24 May 2014, Accepted: 26 June 2014, Published Online: 27 July 2014

Abstract
The purpose of this study is to develop and validate a simple, rapid, sensitive, and precise, degradation studies for Cinacalcet Hcl drug by RP-HPLC method as per ICH guidelines. The HPLC analysis used a reversed phase Agilent Zorbax C18 (250X4.6,5µm) column, a mobile phase constituted of buffer solution and methanol (30:70). The buffer was composed of 1ml orftho phosphoric acid in 1000 ml of water and adjusts PH 2.1 with ortho phosphoric acid. Column temperature is 30oc. This method in wavelength is detecting used for PDA detector and 10ml was injected. The retention time for cinacalet was 3.7min. The validation data showed that the method is sensitive, specific and reproducible for the determination of cinacalcet in the dosage form. The accuracy of the method was found to be 101%. Linearity is not less than 0.99. precission was found to be 99%. LOD and LOQ were found to be 2.913 and 9.709 ng spot-1. Degradation studies in retention time are 3.7min.
Keywords: Cinacalet Hcl, HPLC, Agilent Zorbax C18, validation, degradation studies.

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