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ISSN 2063-5346
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RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF PEMAFIBRATEUSING DESIGN OF EXPERIMENTS APPROACH

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Sai Datri A*, Nataraj Ks, Lakshmana Rao A
» doi: 10.31838/ecb/2023.12.s3.611

Abstract

The present work objective is to develop & validate a simple, accurate & economical RP-HPLC practice for the estimation of Pemafibrate by means of Design of Experiments Approach, which was suitable for multivariate optimization of method. The multinomial equation is a valuable analytical instrument used to investigate the connection among measured reactions and independent factors, and it is especially useful for charting responses across an experimental space to establish the most effective approach. The critical method parameters (CMPs) were optimized using the Box-Behnken Design. Design expert software was equipped for the study. Chromatographic separation was done on Inertsil ODS column with specifications 150mm x 4.6mm, 3.5μm at ambient temperature. The predicted and optimized data from the software consisted of Acetonitrile as an organic phase with a proportion of 59.99% at pH 4.007 with 0.9 ml/min flow rate brought the desirability function of 1. The UV detector was adjusted at 239.4 nm. Validation and Stability Assessment of an Optimized Chromatographic Method with High Linearity and Correlation Coefficient.

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