DEVELOPMENT AND VALIDATION OF A RELIABLE, PRECISE AND STABILITY-INDICATING RP-HPLC METHOD FOR ESTIMATION OF OZENOXACIN IN PHARMACEUTICAL FORMULATIONS: A REVIEW

Analytical method development and validation are essential components of pharmaceutical quality control to ensure the safety, efficacy, and stability of drug products. Ozenoxacin is a non-fluorinated quinolone antibiotic widely used in topical pharmaceutical formulations for the treatment of bacterial skin infections. Accurate estimation of this drug in dosage forms is necessary to maintain product quality and meet regulatory requirements. Reverse Phase High- Performance Liquid Chromatography (RP-HPLC) has emerged as a preferred analytical technique due to its high sensitivity, precision, and ability to separate active pharmaceutical ingredients from degradation products and excipients.This review presents a comprehensive overview of the development and validation of a reliable, precise, and stability-indicating RP-HPLC method for the estimation of Ozenoxacin in pharmaceutical formulations. The review discusses key aspects of method development, including selection of chromatographic conditions, mobile phase optimization, and detection parameters. Emphasis is placed on validation parameters such as linearity, accuracy, precision, specificity, robustness, and sensitivity, in accordance with international regulatory guidelines. Additionally, the importance of forced degradation studies in establishing the stability- indicating nature of the method is highlighted. Overall, this review aims to provide useful insights for researchers and analysts involved in pharmaceutical analysis and quality control of Ozenoxacin formulations. Keywords: Ozenoxacin; RP-HPLC; Stability-indicating method; Method validation; Pharmaceutical analysis