Quality by Design Approach for the Development and Validation of LC method for the Estimation of in-Vitro release of Raloxifene hydrochloride in Dosage Formulation Rao G. Vishnu Vardhana1, Rao V. Srinivasa2, Ramakrishna K.1,* 1Department of Chemistry, GITAM Institute of Science, GITAM University, Visakhapatman, India 2Analytical Research and Development, Syngene International Ltd, Biocon Park, Bommasandra Industrial Estate, Bangalore, India *Corresponding Author E-mail: karipeddirk@gmail.com
Online published on 1 January, 2016. Abstract The present study describes the quality by design based approach for the development and validation of LC method for the estimation in-vitro release of Raloxifene (RXF) hydrochloride in formulation dosage. The development activity is conducted by the HPLC technique with the UV detector. Validation activity is planned and completed based on the International Conference on Harmonization (ICH) guidelines. The method uses an Inertsil ODS 3V 150x 4.6, 5.0 μm HPLC column with a mobile phase consisting 500 mL of buffer (0.1% Trifluoro acetic acid) and 500 mL Methanol. The UV detector set at 287 nm. All the experiments are carried out at column temperature 350 C column oven temperatures with 1.0ml/min flow rate. The method was validated for specificity, linearity, accuracy, precision and robustness. Robustness had established, to estimate the impact of minor changes in evaluation parameters. Design expert was applied, and a 23 full factorial design was used to observe the influence of factors in robustness study. Top Keywords Raloxifene hydrochloride, Dissolution, Liquid Chromatography (LC), Validation, Quality by design, ANOVA. Top |