Abstract

QUALITY BY DESIGN (QbD) APPROACH TO DEVELOPMENT OF ANALYTICAL RP-HPLC METHOD FOR REGADENOSON AND BALOFLOXACIN

Parvin I. Shaha*, Mirza Shahed Baig and Shaikh Sayeed-Ur-Reheman

ABSTRACT

Quality by design (QbD) refers to the achievement of certain predictable quality with desired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments. The present study describes the development of a comprehensive science and risk based RP-HPLC method and subsequent validation for the analysis of Regadenoson and Balofloxacin using a quality by design approach. Experimental designs were applied for multivariate optimization of the experimental conditions of RP-HPLC method. Interaction of independent factors on the depended factor such as tailing factor was studied for both drug. Box Behenken Experimental Design was used to study response surface technique and to study in depth the effects of these independent factors. The optimized chromatographic conditions of HPLC method for regadenoson were water (0.1% o-phosphoric acid): methanol (60:40) as mobile phase, flow rate 1.2 ml/min, wavelength 247. And for Balofloxacin were flow rate 1ml/min, pH 5.7 and Phosphate buffer: Acetonitrile (70:30) as mobile phase. The optimized method condition was validated according to ICH guidelines to confirm LOD and LOQ, linearity, accuracy and precision. The proposed method can be used for routine analysis of Regadenosone and Balofloxacin in quality control laboratories.

Keywords: Quality by design, Regadenoson, Balofloxacin, HPLC.