Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study

Document Type : Research Article

Authors

1 Department of Organic and Medicinal Chemistry, Faculty of Pharmacy, University of Sadat City, Sadat City, Egypt.

2 Department of Research and Development (Methodology section), Egyptian Group for Pharmaceutical Industries Egypt.

3 Sanocare for Pharmaceutical Industries, Badr City, Egypt.

4 Department of Analytical Chemistry, Faculty of Pharmacy, University of Sadat City, Sadat City, Egypt.

Abstract

Objectives: A sensitive, selective and rapid HPLC method was developed and validated for sodium hyaluronate quantification. Methods: Chromatographic separation was achieved SCHARLAU C18 column (4.6 x 250 mm, 5µm) at 50°C. The mobile phase consisted of 50 mM phosphate buffer (pH = 7) (100 %, v/v) and at a flow rate of 0.5 mL/min. The column eluent was monitored at 205 nm. The retention time (Rt) of sodium hyaluronate was at 3.17 min. Results: The calibration curve was linear over the concentration range of 80 – 320 µg/mL. The intra- and inter-day reproducibility studies demonstrated accuracy and precision according to ICH guidelines. Conclusion: The developed method can be applied to the analysis of sodium hyaluronate in Hycarenol® eye drops.
 

Keywords

Journal of Advanced Pharmacy Research
Volume 4, Issue 4
October 2020
Pages 147-152

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