A New Validated HPLC Method and Transferred to UPLC for the Determination of Impurities in Ethyl-methyl-carbamic acid-3-[1-hydroxy-ethyl]-phenyl ester
Journal Title: International Journal of Research in Chemistry and Environment (IJRCE) - Year 2012, Vol 2, Issue 4
Abstract
A simple, economic, and time efficient HPLC method has been developed and transferred to UPLC, subsequently validated for the determination of related impurities in Ethyl-methyl-carbamic acid-3- [1-hydroxy-ethyl]-phenyl ester , a key intermediate for Rivastigmine tartarate. The HPLC method was compared with UPLC method with respect to analysis time, efficiency and sensitivity. The chromatographic separation was carried out on Acquity BEH C18 (50 x 2.1, 1.7 um) using 0.01M potassium dihydrogen phosphate buffer, pH-3.0 and acetonitrile in gradient elution. The total run time is 8 minutes within which all related impurities were separated, where as in HPLC the total run time was set to be 50 minutes. The method was validated as per International Conference on Harmonization (ICH) guidelines in terms of limit of detection (LOD), limit of quantitation (LOQ), linearity, precision, accuracy, specificity.
Authors and Affiliations
Potluri Sushmitha, Lakshmi M. , Suryanarayana V.
Keywords
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