Development and Validation of Analytical Method for the Estimation of Omeprazole, Domperidone and Their Related Substances

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 systemat ic 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.