Volume : 12, Issue : 06, June – 2025

Title:

RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ANTIBIOTIC DRUG IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

Authors :

Vishakha Bhaskar Ingole*, Komal Sham Khot, Prof. Sushma Rathod, Dr. L. R. Gandhi, Dr Nitin S. Bhajipale

Abstract :

The present research focuses on the development and validation of a stability-indicating Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the estimation of Ozenoxacin (OZE), a recently introduced antibiotic drug, in bulk and its semisolid pharmaceutical dosage form. Various chromatographic conditions were optimized using an Inertsil C18 column (4.6 × 250 mm) with a mobile phase consisting of Methanol: Phosphate Buffer (60:40, pH 3.5), and detection was carried out at 309 nm. The method demonstrated excellent resolution, specificity, and reproducibility with a retention time of approximately 4.92 minutes. Validation was carried out in accordance with ICH guidelines for parameters including accuracy, precision, specificity, linearity, robustness, ruggedness, LOD, and LOQ. The method showed linearity in the range of 80% to 120% of test concentration with R² value close to 0.9998. Forced degradation studies under acid, base, oxidative, thermal, and UV conditions confirmed the stability-indicating nature of the method. The results revealed that there was no interference from excipients or degradation products. Thus, the proposed RP-HPLC method is accurate, precise, and suitable for routine analysis of Ozenoxacin in pharmaceutical formulations.
Keywords: Ozenoxacin; RP-HPLC; Method Validation; Semisolid Formulation; Stability-Indicating; Forced Degradation; ICH Guidelines; Antibiotic Analysis; Quantitative Estimation.

Cite This Article:

Please cite this article in press Vishakha Bhaskar Ingole et al Rp-Hplc Method Development And Validation Of Antibiotic Drug In Bulk And Its Pharmaceutical Dosage Form, Indo Am. J. P. Sci, 2025; 12(07).

Number of Downloads : 10

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