ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATIONOFOZENOXACINBYUFLCINTOPICALSEMISOLID DOSAGE FORMS
Abstract: Ozenoxacin ointments are available in the market. Ozenoxacin is a novel topical, nonfluorinated quinolone antimicrobialagent.The literature review reveals that there is no official monograph for Ozenoxacin ointment in Indian Pharmacopoeia and also no analytical method reported for the analysis of Ozenoxacin ointments in topical semi solid dosage form by UFLC. Spectrophotometer and RP-HPLC are the reported analytical methods for compounds either individually or in combination with other dosage form. Hence, it was felt that, there is a need of new analytical method development for the determination of ozenoxacinbyuflcintopicalsemi solid dosage forms. Present work is aimed to develop a new, simple, fast, rapid, accurate, efficient and reproducible analytical methoddevelopmentandvalidationforthedeterminationofozenoxacinbyuflcintopicalsemi solid dosage forms. The developed method will be validated according to ICH guidelines, Q2.Retention time of Ozenoxacin wasfound to be 2.717minutes.The %RSDof nine accuracy samples of Ozenoxacin found between 99.0 to 100.90.The system precision is 0.55 %, Intermediate precision for day 01 is 0.77% and the intermediate precision for Day 02 is 0.62%.So the method developed was simple and economical with less analytical time and less solvent usage. And can be adopted in regular Quality control test in Industries.
Institutions
- Institute on Taxation and Economic Policy (US)
Publication Details
- Journal
- Zenodo (CERN European Organization for Nuclear Research)
- Published
- 2025-08-22
- DOI
- https://doi.org/10.5281/zenodo.16927470
- Primary Topic
- Prenatal Screening and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 0.00