Determination of Sodium, Potassium, and Magnesium as Sulfate Salts in Oral Preparations Using Ion Chromatography and Conductivity Detection

Abstract

An ion chromatography technique with conductivity detection was selected as an analytical tool for the simultaneous indirect determination of sodium sulfate, potassium sulfate, and magnesium sulfate via their respective cations. The method was developed and validated for the quantitative assay of the inorganic salts under study in oral pharmaceutical dosage forms. Chromatographic separation was achieved on a Dionex®IonPac® CS16 column (250 × 5 mm) column using the gradient elution method. A mobile phase-A consisting of methane sulfonic acid (6.7%, v/v) in Milli-Q water, which is used together with Milli-Q water, was used as a mobile Phase-B. The flow rate was 1.2 mL/min. The retention times of sodium, potassium, and magnesium as sulfates were 7.8, 12.8, and 16.2 min, respectively. The method was validated according to ICH guidelines and showed good linearity and accuracy results within concentration ranges of 80.0–240.0, 20.0–60.0, and 4.5–13.5 ppm for sodium, potassium, and magnesium as sulfates, respectively. The relative standard deviation results for intra- and inter-day precision were less than 1.0%. The method was applied successfully for determination of the analytes under study in their mixed pharmaceutical oral solution and found suitable for their routine and stability analysis.

Keywords

• ion chromatography
• sodium sulfate
• potassium sulfate
• magnesium sulfate
• method validation
• oral dosage form