Abstract

ANALYTICAL QUALITY BY DESIGN (AQbD): APPLICATION TO DEVELOPMENT AND VALIDATION OF THREE SPECTROPHTOMETRIC METHODS FOR DETERMINATION OF OXYBUTININ HYDROCHLORIDE IN PHARMACEUTICALS

*Sagar Suman Panda, Bera Venkata Varaha Ravi Kumar, Aswini Kumar Behera, Biswajit Sahu

Abstract

Three spectrophotometric methods viz. zero order, area under curve (AUC) and second derivative were developed for determining oxybutnin hydrochloride (OXN) in bulk and, pharmaceutical formulation. A novel approach of quality by design (QbD) was followed to develop robust spectrophotometric methods. Key method variables such as scanning speed and sampling interval were optimized using DoE and their effect on absorbane was studied. The method linearity was observed over a range of 10-80μg/mL of OXN. The developed method was also subjected to validation studies such as specificity, accuracy (>98%), precision (< 2%) etc. Utilizing QbD approach ensured development of analytical methods devoid of any quality risks. The developed methods were found suitable for determining analyte in both bulk as well as in drug formulation. Overall the methods were reliable, robust and possess the potential of application in routine quality control testing purposes.

Keywords: Oxybutinin, AQbD, spectrophotometry, validation, robustness.