Development of method for determination of sucralfate in suspension by High-performance liquid chromatography

Sucralfate suspension is primarily used as a treatment for ulcers and gastroesophageal reflux disease. Globally, this substance has been approved for various indications, including the management of peptic ulcer disease, stress ulcers, oral mucositis, as well as radiation-induced mucositis and esophagitis. This study aims to provide a reference quantitative method by high-performance liquid chromatography (HPLC) for drug manufacturers to control the quality of their sucralfate suspension product with the available conditions at their facility, and to serve as a tool in the field of drug research and development. As sucralfate is a substance that does not absorb UV-VIS light, the UV-VIS detector cannot be used. For such compounds, detectors like RID (Refractive Index Detector), ELSD (Evaporative Light Scattering Detector), or Charged Aerosol Detector (CAD) can be utilized. Among these, RID is the detector chosen for this study due to its popularity, ease of use, and low cost. The chromatographic conditions are as follows: Column: L8 (NH2), 300 × 3.9 mm. Detector: Refractive Index Detector (RID). Mobile phase: ammonium sulfate (132 g/L) adjusted to pH 3.5 ± 0.1 with phosphoric acid, resulting in a phosphoric acid concentration of approximately 1.8 × 10⁻² M. Column temperature: 30°C; Injection volume: 50 µL; Flow rate: 1 mL/min. This method is applicable, and the solvents and chemical reagents are common and available in testing centers and quality control departments at production facilities equipped with HPLC machines.