DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF OMEPRAZOLE, DOMPERIDONE AND THEIR RELATED SUBSTANCES.

Abstract

The present study describes the development of  a  comprehensive  science  and  risk  based  UPLC  method  and  subsequent  validation  for  the  simultaneous analysis  of  related substances of omeprazole and domperidone active pharmaceutical ingredient (API)  using a quality by design approach. An efficient experimental design based on systematic scuti ng of all three  components of the UPLC method (column temperature, mobile phase A and B) is presented. The optimized UPLC conditions (column temperature of 50°C, mobile phase A organic modifier (buffer: methanol, 900: 50), mobile phase B organic modifier (acetonitrile: methanol, 830: 170)) resulted in fully resolved peaks. The QbD based method development helped in generating a design space and operating space with the knowledge of all method performance characteristics and limitations and successful method robustness within the operating space.