Analytical Method Development and Quality Evaluation of Locally Compounded Oral Rehydration Salts at Hospital Pharmacies in Sokoto State

Oral rehydration salts are an essential component of diarrhoeal disease management, particularly in paediatric settings in North West Nigeria where childhood diarrhoea remains a leading cause of mortality. In Sokoto State, compounding of ORS at hospital pharmacies is common due to inadequate supply of prepackaged formulations. Ensuring the chemical accuracy and quality of compounded ORS is critical to clinical safety. This study developed and validated analytical methods for simultaneous quantification of sodium, potassium, chloride, and glucose in compounded ORS preparations from six hospital pharmacies in Sokoto State. Ion chromatography was used for electrolyte determination, and glucose was quantified by enzymatic colorimetric assay and corroborated by refractometric analysis. Method validation was conducted per ICH Q2(R1) guidelines. Physicochemical parameters including osmolarity, pH, and sterility were also assessed. Wide variability was found in electrolyte concentrations across compounded batches, with sodium content ranging from 68 to 121 mmol/L compared to the WHO standard of 75 mmol/L. Potassium concentrations were below the standard specification in 40% of samples. Three batches failed pH specification. Hypo-osmolar and hyperosmolar formulations were both represented among the collected samples. These analytical findings demonstrate that compounded ORS quality in Sokoto State hospital pharmacies is inconsistent and potentially clinically unsafe. Standardised compounding protocols and mandatory quality testing before dispensing are urgently recommended. Keywords: oral rehydration salts, compounding, ion chromatography, Sokoto State, quality control.