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.
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