Original ArticleIndian Journal of Pharmaceutical Education and ResearchVol. 55 | Issue 2 | 2021 | pp. 607–613Open access
Stability Indicating Assay Method Development and Validation for Simultaneous Estimation of Ofloxacin and Ornidazole by RP-HPLC in Bulk: An Application to Tablet Formulation and Dissolution Studies
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- 1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-Udupi, Karnataka, INDIA.
Published in Indian Journal of Pharmaceutical Education and Research
Correspondence: Vasantharaju SG
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-Udupi, Karnataka, INDIA.
Email: sgvasanth65@gmail.com
Copyright: © 2021 Manuscript Technomedia. This is an open access article.
- Published:
- Jan 1, 2021
- Received:
- Jul 22, 2020
- Accepted:
- Mar 1, 2021
- DOI:
- 10.5530/ijper.55.2.100
How to cite
D’Souza, K., Syeda, A., Khatal, P., Sathyanarayana, M. B., & SG, V. (2021). Stability Indicating Assay Method Development and Validation for Simultaneous Estimation of Ofloxacin and Ornidazole by RP-HPLC in Bulk: An Application to Tablet Formulation and Dissolution Studies. Indian Journal of Pharmaceutical Education and Research, 55(2), 607–613. https://doi.org/10.5530/ijper.55.2.100
Abstract
Aim: The present article focuses on development of sensitive, simple, precise, accurate and inexpensive stability indicating assay method for the simultaneous estimation of Ofloxacin and Ornidazole in bulk was established using RP-HPLC. Materials and Methods: The separation was done with C18 Phenomenex Hyperclone BDS column (250×4.6mm, 5μ) at a temperature of 25°C using a mobile phase of acetonitrile: pH 5.8 ammonium acetate buffer of ratio 25:75 with a flow rate of 1ml/min. The detection was done at 293nm and 311nm and the retention time for Ofloxacin and Ornidazole was 4.278 min and 6.750 m respectively. Results: The method was seen to be linear over the range of 2-16μg/ml for both drugs. The method was precise and robust with LOD of 0.331 and 0.360 and LOQ of 1.005 μg/ml and 1.092 μg/ml for Ofloxacin and Ornidazole respectively. The drugs were subjected to stress conditions in acidic, alkaline, oxidative, thermal and photolytic conditions. Conclusion: The method for this simultaneous estimation was found to be accurate, precise, fast and simple with a run time within 8 min. This method developed was applied with success for the assay and dissolution studies in tablet formulation.
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Article metadata
| Title | Stability Indicating Assay Method Development and Validation for Simultaneous Estimation of Ofloxacin and Ornidazole by RP-HPLC in Bulk: An Application to Tablet Formulation and Dissolution Studies |
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| Authors | Kevita D’Souza; Alisha Syeda; Parnika Khatal; Muddukrishna Badamane Sathyanarayana; Vasantharaju SG |
| Affiliations | Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal-Udupi, Karnataka, INDIA. |
| Corresponding author | sgvasanth65@gmail.com |
| Journal | Indian Journal of Pharmaceutical Education and Research |
| Volume / Issue | Vol. 55, Issue 2 (2021) |
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