QBD approach in HPLC method development and validation of furazolidone

QbD principles for establishment of a HPLC method for Furazolidone with improved robustness and performance. On the basis of the initial prioritization and factor screening studies, the highly influential factors were identified and subsequently optimized for improving the method robustness. The response surface mapping particularly facilitated improved understanding of the factor–response relationship and interactions associated with them. Extensive validation studies further ensured high degree of method robustness with extreme variation in the key variables influencing the method performance. In addition, the method showed improved sensitivity for the Furazolidone much beyond the values reported in the literature.