Ensuring Therapeutic Consistency And Safety: A Comprehensive Physicochemical Quality Assessment Of A Commercially Available Potassium Gluconate Oral Suspension

Abstract

The present study was conducted to perform a comprehensive quality control analysis of KALIGON 15% syrup, a pharmaceutical product, to verify its compliance with the specifications of the European Pharmacopoeia.

A series of analyses were performed on the finished product. The organoleptic properties (color, odor, and consistency) were evaluated. Physicochemical parameters, including pH, density, and average fill volume, were measured. The concentration of the active ingredient, potassium gluconate, and of potassium ions was determined using a calibration curve method. Finally, High-Performance Liquid Chromatography (HPLC) was employed for the identification and quantitative assay of the preservatives, methylparaben (Nipagine) and propylparaben (Nipazol).

The results obtained show that the organoleupeptic evaluation yielded a syrup with a slightly yellowish color, a raspberry odor, and a homogeneous consistency. The physicochemical analysis produced a pH of 5.67, a density of 1.3097 g/cm³, and an average fill volume of 124.22 ml. The assay for the active ingredient determined the potassium gluconate concentration to be 14.47 g/100ml and the potassium ion concentration to be 2.41 g/100ml. Finally, the analysis of preservatives found the Nipagine (methylparaben) concentration to be 0.09664 g/100ml and the Nipazol (propylparaben) concentration to be 0.02085 g/100ml.

All of these measured values fall within their respective acceptance ranges as specified by the European Pharmacopoeia.