METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF OZENOXACIN IN PHARMACEUTICAL PRODUCTS BY MICROBIOLOGICAL ASSAY

Abstract

Ozenoxacin is a novel non-fluorinated topical antibiotic belonging to the quinolone family. HPLC techniques are normally used for the quantification of the efficacy of ozenoxacin, however, the HPLC technique is unable to infer bioactivity against microorganisms. The goal of this article was to augment and authenticate an accurate, sensitive, and yet simple, commercial two-stage cylinder plate (2+2) assay for determining the efficacy and bioactivity of ozenoxacin in pharmaceutical products, which has not been published in any of the scientific journals. This study is based on the development of a bioassay technique for estimating ozenoxacin in pharmaceutical products. In this investigation, the microbiological assay was performed with 08 bacterial strains and 02 fungal strains, from which Salmonella enterica serotype Abony MTCC-3858 was selected as the most suitable organism against ozenoxacin based on sharp and clear zone of inhibition. The advanced mathematical approach to linearity, precision and accuracy has been successfully verified and validated. The mean potency recovery value was estimated to be 100.83 % for ozenoxacin cream. In this study, validated methods were used to assess the linearity (r2 =0.9859); the intermediate precision RSD between days was 1.01 %; The mean precision RSD between analysts was 1.04 % and accuracy was 100.67 %, RSD = 0.65 %. Bioassay was optimized by investigating several factors such as robustness by buffer diluent used for standard and sample preparation (phosphate buffer pH 8.0; RSD=0.37 %), inoculum concentration (0.3 %; RSD=0.44 %) and incubation temperature (30 o C; RSD=0.80 %). The result shows that the efficacy of ozenoxacin in pharmaceutical products can be estimated by bioassay technique for quality control purpose.