Author: S. R. Rambhad and H. Dave

DOI: http://doi.org/10.31788/RJC.2026.1919531

Levosulpiride, an atypical antipsychotic, is primarily used to treat psychiatric conditions, while Rabeprazole, aproton pump inhibitor, is indicated for managing various gastrointestinal disorders. When combined, Levosulpirideand Rabeprazole Sodium are commonly prescribed for the treatment of gastro-oesophageal reflux disease, indigestion, as well as duodenal and gastric ulcers. Studying the degradation properties of combined activepharmaceutical ingredients is a critical aspect of pharmaceutical research, essential for ensuring the safety, efficacy, and stability of drug formulations throughout their shelf life. Based on this, the main aim of the present researchwasto examine the degradation behaviour of Levosulpiride and Rabeprazole Sodium, in combination, using liquidchromatography combined with mass spectrometry. Chromatographic separation was achieved using a Hypersil BDS C18 column with a specified mobile phase flow rate of 1.0 mL/min. A gradient mode was employed for theseparation of Rabeprazole Sodium and Levosulpiride using a mobile phase consisting of 2 mMammoniumformate(Mobile Phase A) and acetonitrile (Mobile Phase B), with detection carried out at 210 nm. Levosulpiride andRabeprazole Sodium were exposed to various stress conditions, and their degradation products were subsequentlyanalyzed using LC-MS. Few degradation products were successfully identified, corresponding to degradation under acidic, basic, and oxidative conditions, respectively. The characteristic degradation behaviour under each specificstress condition was quantified and expressed as a percentage. In conclusion, novel impurities in the selectedcombination provide crucial stability insights, supporting formulation, quality control, and future research.

Keywords: Degradation Properties, Forced Degradation Studies, Levosulpiride, Liquid Chromatography–Mass Spectrometry, Rabeprazole Sodium.