Abstrato

Implementation of Quality by Design Approach to Analytical Method Development and Validation for Estimation of Morniflumate Pharmaceutical Dosage Form

Bhavna Chandnani

The effectiveness of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) for the management of pain in osteoarthritis and other Musculoskeletal diseases in well documented. The role of NSAIDs is less clear in the treatment of condition involving soft tissues inflammation, including the airways, Ear-Nose-Throat (ENT) system and urogenital tract. Morniflumate has a 30 year history of clinical use, particularly for the treatment of pain associated with pediatric ENT infection.

A simple, rapid, accurate and precise RP-UPLC analytical method with UV detection has been developed for determination of morniflumate in API and tablet dosage form. A QBD (Quality by Design) approach was successfully applied. The method was validated accordance to ICH guidelines. The objective of this present study was to develop and demonstrate an integrated QBD (Quality by Design) approach to develop and validate the method for morniflumate estimation in dosage form. The drug was subjected to alkali, acidic, oxidative degradation stress. All the peaks of degraded products were resolve from standard drug peak condition.