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.

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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
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article

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATIONOFOZENOXACINBYUFLCINTOPICALSEMISOLID DOSAGE FORMS

Zenodo (CERN European Organization for Nuclear Research)
Prenatal Screening and Diagnostics
article

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATIONOFOZENOXACINBYUFLCINTOPICALSEMISOLID DOSAGE FORMS

article en

Abstract

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.

Zenodo (CERN European Organization for Nuclear Research)
Institute on Taxation and Economic Policy (US)
Industry, innovation and infrastructure
Openalex Percentile: Top 32%
Prenatal Screening and Diagnostics
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