APPLICATION OF QUALITY BY DESIGN FOR DEVELOPMENT OF ANALYTICAL RP-HPLC METHOD FOR RANITIDINE HCL

The concept of Quality by Design (QbD) has recently been adopted for the development of pharmaceutical processes to ensure a predefined product quality. Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. In an attempt to reduce rising development costs and regulatory barriers to innovation and creativity, the FDA and ICH have recently started promoting QbD in the pharmaceutical industry. The present study describes a simple, accurate, precise and cost effective reverse phase high performance liquid chromatographic (RP-HPLC) Method for determination of Ranitidine HCl bulk marketed tablet formulation. The systematic approach, one of the parts of QbD was use for the analytical method development. Detection was done using UV detector at 314 nm. Optimization was done by response surface methodology, applying a three level Box Behenken design with three centre points. Three factors selected were flow rate, pH and Buffer: Acetonitrile concentration in mobile phase composition. The optimized chromatographic method was validated according to the International Conference on Harmonization (ICH) Q2 (R1) guidelines for linearity, range, accuracy and robustness. The separation was carried on Phenomenex C18 (4.6 ID mm×150mm; 5μm) with mobile phase 0.02M phosphate Buffer: Acetonitrile (25:75 v/v). Flow rate 0.9 ml/min and at pH 3.0, which was optimized with help of design expert software. High linearity of the developed method was confirmed over concentration range of 10-50 μg/ml and correlation coefficient of 0.9996. The percentage RSD for precision and accuracy of the method was found to be less than 2%. Peak was obtained at retention time of 2.139 min.