Green validated stability indicating HPLC method of Dihydrostreptomycin Sulfate in Pharmaceutical Dosage Form | ||
| Egyptian Journal of Chemistry | ||
| Article 19, Volume 66, Issue 6, June 2023, Pages 179-185 PDF (790.46 K) | ||
| Document Type: Original Article | ||
| DOI: 10.21608/ejchem.2022.153206.6641 | ||
| Authors | ||
| Emad M. Abd Halim1; Mohamed A. Amin2; Mohamed A. Ali* 3 | ||
| 1Department of Chemistry, Zagazig University, Zagazig 44519, Egypt. | ||
| 2Quality Control Manager, Pt CELL for Pharmaceutical Industries Co. 10th of Ramadan city 44629, Egypt | ||
| 3School of Biotechnology, Badr University in Cairo (BUC), Badr City, Cairo, 11829, Egypt | ||
| Abstract | ||
| Background: Dihydrostreptomycin Sulfate (DHSTR) is a bactericidal aminoglycoside antibiotic derived from streptomycin. It is frequently utilized in the prevention and treatment of animal diseases. Unreasonable usage or misuse may readily affect human health. Objective: This work was committed to creating a simple, sensitive, and accurate stability-indicating high-performance liquid chromatographic technique with ultraviolet detection (HPLC-UV) to assess DHSTR in pharmaceutical formulations. Methods: Agilent 1200 system was used. Mobile phase was isocratic consisted of 0.1% Phosphoric acid 85% at a flow rate of 1.5 mL min-1, A 20 μL amount of injection was used, and the UV detector was set at 210 nm. The chromatographic separation of DHSTR was performed on the Phenomenex, Prodigy, ODS3, (150 x 4.6 mm, 5 µm). Results: The method was linear (r2 greater than 0.999) in the 200.0 – 800.0 μg mL-1concentration range. A retention time of 1.67 minutes The detection and quantification limits were 0.85 and 2.57 μg mL-1, respectively. The method's accuracy, expressed as recovery, was 100.64%, with relative standard deviations less than two. Thus, the process can be considered stability-indicating and can be used effectively in pharmaceutical formulations to determine dihydrostreptomycin Sulfate. Conclusion: A stability-indicating HPLC-UV technique was devised and validated for testing DHSTR stability in pharmaceutical formulations. The approach satisfied the regulatory standards of the International Conference on Harmonization (ICH). The findings revealed that the approach would be greatly appreciated when utilized in quality control and stability tests for DHSTR. | ||
| Keywords | ||
| HPLC; Dihydrostreptomycin; UV detector; Method validation; Veterinary drugs | ||
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