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CC BY 4.0 · Journal of Health and Allied Sciences NU 2024; 14(04): 532-537
DOI: 10.1055/s-0044-1779616
Original Article

RP-HPLC-DAD Method Development and Validation for 1,3,4-Oxadiazole Derivative to Evaluate Its Forced Degradation Behavior and Stability

Autor*innen

  • Shridhar Narayan Deshpande

    1   Department of Pharmaceutical Chemistry, NGSM Institute of Pharmaceutical Sciences (NGSMIPS) Nitte (Deemed to be university), Mangalore, Karnataka, India

  • Revana Siddappa BC

    1   Department of Pharmaceutical Chemistry, NGSM Institute of Pharmaceutical Sciences (NGSMIPS) Nitte (Deemed to be university), Mangalore, Karnataka, India

  • Kartik Bhairu Khot

    2   Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences (NGSMIPS) Nitte (Deemed to be university), Mangalore, Karnataka, India

  • Gupta Dheeraj Rajesh

    1   Department of Pharmaceutical Chemistry, NGSM Institute of Pharmaceutical Sciences (NGSMIPS) Nitte (Deemed to be university), Mangalore, Karnataka, India

  • Cynthia Lizzie Lobo

    2   Department of Pharmaceutics, NGSM Institute of Pharmaceutical Sciences (NGSMIPS) Nitte (Deemed to be university), Mangalore, Karnataka, India
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Abstract

In the current study, a straightforward high-performance liquid chromatographic (HPLC) approach was developed and validated to identify a novel drug compound called 5-(4-bromophenyl)-N-(2-chloro-4-nitrophenyl)-1,3,4-oxadiazol-2-amine (A3). By putting the compound's solution under hydrolytic, oxidative, and photolytic stress, the method's capacity to detect stability was put to the test. A gradient mobile phase of acetonitrile, orthophosphoric acid, and methanol (90:051:05 v/v), at a flow rate of 1.00 mL/min, was used for the chromatographic separation on a C18 column (Promosil, 5μ, 4.60 250 mm), which was maintained at 40°C and a photodiode array detector was used for detection. At concentrations between 10 and 100.00 μg/mL, Beer's rule was observed. The recovery (99.25–100%, standard deviation [SD] 5%), intraday accuracy and precision (98.62–99.91%, relative standard deviation [RSD] 5%), interday accuracy and precision (96.25–99.91%, RSD 5%), and intermediate accuracy and precision (98.10–99.91%, RSD 5%) all indicated that the developed method was reliable, repeatable, reproducible, and robust. In cases of thermal and moisture deterioration, respectively, the compound's peak resolution and selectivity factors from the nearest resolving peak revealed specificity and selectivity. The selected synthesized compound barely broke down under oxidative and alkaline hydrolytic stress. However, the compound was resistant to photolysis in neutral and acidic environments. The results of this study demonstrate the sensitivity, specificity, and selectivity of the established approach for quality control, stability testing, and preformulation investigations.

Keywords

1,3,4-oxadiazole derivative - column chromatography - RP-HPLC - forced degradation


Publikationsverlauf

Artikel online veröffentlicht:
10. Juni 2024

© 2024. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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