Analytical Method Development and Validation of Chloro Impurity and Methyl Ester Impurity by using RP-HPLC

Suryanarayana Gottapu*¹, Hirdayesh kumar Vatsa¹, B. Anitha^2
1Monad Univeristy, Hapur, Rajasthan, India
²SARC (Scientific and Applied Research Center), Hyderabad, Telangana, India

A B S T R A C T
A simple and precise RP-HPLC method was developed for the determination of Apixaban impurities like Chloro impurity and Methyl ester impurity. The chromatographic separation was achieved on an Zorbax Bonus RP (250 X 4.6mm) column with a mobile phase contain the gradient mixture of the solvents (Acetonitrile : water) in the ratio of  90:10(v/v). The eluted compounds were monitored at 270nm and the run time was 35mints.The method is repeatable and can be used for routine analysis of Apixaban in bulk and in pharmaceutical formulation. Hence it is more effective, sensitive and the impurities profile can be analyzed easily through this method. The development and validated RP-HPLC method is applied for identification of eluted the impurities.
Keywords: RP-HPLC, Method Validation, Chloro impurity, Methyl ester impurity.