Development and validation of RP-HPLC method for estimation of process related impurity in nimodipine bulk and formulation
2015
A Simple, linear, precise, accurate, robust and selective RP-HPLC method has been developed for the estimation of Nimodipine impurity in bulk and formulation. The methanol: acetonitrile: water in proportion of (35v:40v:25v) as mobile phase was used. At the flow rate of 0.8ml/min. The HPLC system consisting of LC20AD Prominence Liquid Chromatography SPD 20-A Shimadzu Japan. The UV-VIS detector and C18 column with dimension on 250×4.6 mm was used at wavelength 234 nm. Finally Nimodipine impurity was quantified from bulk Nimodipine and its tablet formulation. It was revealed that amount of impurity present in tablet was found to be 0.0876% and in the bulk 0.0219% respectively. Thus, Nimodipine impurity was found to be within the limit which was given in ICH guidelines. (Not more than 0.1%)
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