Efficient HPLC-ELSD analysis of sodium and phosphate in aripiprazole extended-release injectable suspensions using trimodal column technology

Abstract

The quantification of inorganic ions such as sodium and phosphate ions in pharmaceutical formulations is crucial for ensuring the consistency and safety of the drug product. This study presents a robust and selective HPLC method coupled with an Evaporative Light Scattering Detector (ELSD) for the simultaneous determination of sodium and phosphate ions in aripiprazole extended release injectable suspensions. A trimodal stationary phase column, offering a combination of reversed-phase/cation-exchange/anion-exchange mechanisms, was employed to enhance selectivity and retention of the highly polar analytes. The use of ELSD enabled the detection of non-chromophoric inorganic ions with satisfactory sensitivity and reproducibility. Validation of the method was performed in accordance with ICH guidelines, demonstrating acceptable linearity (R² > 0.99), precision (RSD < 10%), accuracy (recoveries between 95–105%) and LOD values suitable for routine quality control. The method showed adequate robustness in the studied formulations. This novel application of a trimodal column with HPLC-ELSD offers a powerful alternative to ion chromatography or ICP-MS, providing a simpler and cost-effective approach for inorganic ion analysis in complex pharmaceutical matrices.