Articles Accepted

Method Development and Validation for Quantification of Ozenoxacin in Pharmaceutical Products by Microbiological Assay
by Dr. Prasad, 11 Apr 2022
Co-Author(s): Piyush Kumar,Prasad Thota,Bhavna Kumari,Manoj Kumar Pandey,Anil Kumar Teotia,Rajeev Singh Raghuvanshi

Ozenoxacin is a novel non-fluorinated topical quinolone antimicrobial drug. HPLC techniques are usually used for quantitative estimation of potency of ozenoxacin, however HPLC technique is not capable to conclude bioactivity against microorganisms. The objective of this article was to expand and authenticate an easy, susceptible, accurate and commercial two-level cylinder plate (2 + 2) microbiological assay for determination of potency and bioactivity of ozenoxacin in pharmaceutical product which hasn't been published in any of the scholarly journals. The aim of this article is to develop a bioassay technique for the estimation of ozenoxacin in pharmaceutical preparation. The microbiological assay was carried out with 08 bacterial strains and 02 fungal strains, Salmonellae enterica serotype abony MTCC-3858 was selected as the most appropriate organism against ozenoxacin. The advanced mathematical approach with respect to linearity, precision and accuracy was successfully verified and validated. The mean potency recovery value was estimated as 100.83% for ozenoxacin cream. An evaluated validation method showed linearity (r2=0.9859); the intermediate precision RSD between days was 1.01%; intermediate precision RSD between analyst was 1.04% and accuracy 100.67%, RSD=0.65%. Outcome demonstrates that the potency of ozenoxacin in pharmaceutical products can be estimated through bioassay technique for quality control purpose.

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