Validated Stability-Indicating RP-HPLC Method for Quantitative Determination of Sodium Hyaluronate in Pharmaceuticals and Cosmetic Formulations
TL;DR
The method was simple, precise, accurate, robust, robust, and rapid, making it suitable for quantifying sodium hyaluronate in different types of pharmaceutical products and cosmetics.
Abstract
This study reports the development of a new stability-indicating reverse-phase high-pressure liquid chromatography (RP-HPLC) assay method to quantify sodium hyaluronate in different types of pharmaceutical dosage forms and various cosmetic products. The technique used is isocratic elution on both Waters Xbridge and Kromasil C18 column (250 × 4.6 mm, 5 µm particle size) with a mobile phase containing buffer at pH 4.5 (Sodium dihydrogen phosphate 0.01 M solution) and methanol (85:15 v/v). UV detection at 205 nm was used to monitor the analyte. However, Waters Xbridge C18 column (250 × 4.6 mm, 5 µm particle size) was finally found suitable for Sodium hyaluronate. Sodium hyaluronate showed linearity over the concentration range of 7.5–60 µg/ml and a retention time of roughly 2.90 minutes. The Limit of Detection (LOD) and Limit of quantification (LOQ) were 0.15 and 0.30 µg/ml respectively. The ICH (International Council for Harmonisation) recommendations were followed in determining the analytical performance parameters. The method was simple, precise, accurate, robust, and rapid, making it suitable for quantifying sodium hyaluronate in different types of pharmaceutical products and cosmetics. This analytical method is specialized for quantification of Sodium hyaluronate present in various formula of pharmaceuticals and cosmetics which made it unique from other analytical method.