Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study | ||
| Journal of Advanced Pharmacy Research | ||
| Article 3, Volume 4, Issue 4, October 2020, Pages 147-152 PDF (570.22 K) | ||
| Document Type: Research Article | ||
| DOI: 10.21608/aprh.2020.31754.1110 | ||
| Authors | ||
| Mohammed El-Behairy1; Mostafa Taher2, 3; Inas Abdallah* 4 | ||
| 1Department of Organic and Medicinal Chemistry, Faculty of Pharmacy, University of Sadat City, Sadat City, Egypt. | ||
| 2Department of Research and Development (Methodology section), Egyptian Group for Pharmaceutical Industries Egypt. | ||
| 3Sanocare for Pharmaceutical Industries, Badr City, Egypt. | ||
| 4Department 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 | ||
| HPLC; sodium hyaluronate; SCHARLAU; ICH guidelines; Hycarenol® eye drops | ||
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