Development of Ion pair Chromatography Method for Assay of Telaprevir by Response Surface Methodology

Abstract

Response surface methodology approach has been utilized for the assay of Telaprevir in pure and formulation using ion-pair chromatography.  In this,  A risk assessment approach (Control-Noise-Experiment) has been used for identifying the risk factors, i.e. Percentage of Organic Modifier (% Acetonitrile), Buffer’s pH and flow rate of the method. The Central Composite design was applied to optimize the critical method parameters (CMPs) and to find out the Design space (DS) of the method. The coefficient of correlation (R2), %CV and Lack of fit are utilized for the evaluation of method responses (Retention time and Asymmetric factor Evaluation of model is justified by two diagnostic plots (normal probability plot of residuals and plot of residuals vs predicted values). The mobile phase is Acetate Buffer (20mM) pH 4.4: Acetonitrile (35:65) with 0.9 ml/min of Flow rate. The separation has taken placed in the Eclip Plus C-18 column (250 4.6 mm, 5µm) at 268 nm. The retention time of Boceprevir was found to be 4.6 min. The validation of the optimized method has performed according to ICH guideline. The method has been successfully used for routine analysis of the Telaprevir throughout the life cycle of the product.