RP-HPLC Method of Drug Development and Validation for the Determination of Ezetimibe using Design of Experiments Approach

Author(s): A. Sai Datri*, K. S. Nataraj and A. Lakshmana Rao


The present research aims to develop and validate a simple and accurate RP-HPLC method for the determination of Ezetimibe by using the Design of Experiments Approach. This approach was useful for multivariate optimization of the method. The critical method parameters (CMPs) were optimized using the Box-Behnken design. Minitab software was equipped for the study. Chromatographic separation was done on Phenomenex C18 column with specifications 150 mm × 4.6 mm × 5 μm at 30°C. The predicted and optimized data from the software consisted of mobile phase 0.02 N Ortho phosphoric acid (OPA) and Acetonitrile (53:47% v/v), pumped at a flow rate of 0.96 ml/min brought the desirability function of 1. The UV detector was adjusted at 232.6 nm. The developed method was shows linearity with a correlation coefficient of 0.999. The optimized chromatographic method was validated as per the guidelines of ICH Q2 (R1). The stability of drug was forcibly studied under different stress conditions.

image 10.4303/jdar/236198

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