Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study
El-Behairy, M., Taher, M., Abdallah, I. (2020). Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study. EKB Journal Management System, 4(4), 147-152. doi: 10.21608/aprh.2020.31754.1110
Mohammed El-Behairy; Mostafa Taher; Inas Abdallah. "Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study". EKB Journal Management System, 4, 4, 2020, 147-152. doi: 10.21608/aprh.2020.31754.1110
El-Behairy, M., Taher, M., Abdallah, I. (2020). 'Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study', EKB Journal Management System, 4(4), pp. 147-152. doi: 10.21608/aprh.2020.31754.1110
El-Behairy, M., Taher, M., Abdallah, I. Straightforward Determination of Sodium Hyaluronate in Active Pharmaceutical Ingredient and Ophthalmic Formulations: Validation and Stability Study. EKB Journal Management System, 2020; 4(4): 147-152. doi: 10.21608/aprh.2020.31754.1110

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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