DEVELOPMENT AND VALIDATION OF HIGH PRESSURE LIQUID CHROMATOGRAPHY ANALYTICAL METHOD FOR RELATED SUBSTANCE OF ACETYLCYSTEINE EFFERVESCENT TABLET

Abstract

The HPLC method was developed specially for the related substances of n-acetyl-l-cysteine (NAC) effervescent tablet formulation where the issue of merging of impurities peaks was observed during the development of the method. So, development was triggered with an aim of separation of all the known possible impurities peaks from that of principal peak of acetylcysteine as well as each four known impurities. Finally the analytical method for related substance of acetylcysteine with a gradient program on HPLC was developed and validated with the mandatory experiments. The related substance method was efficient to separate the co-eluting peaks of impurities and its individual known impurities from the principal peaks specifically for the effervescent formulation. The method was specific, selective and reproducible. Recovery and linearity was also found within the acceptance criteria. Solution stability was also established and evaluated during the method validation. Method was successfully evaluated for robustness using various alterations in the method parameters for its functionalities.