DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE THIN LAYERCHROMATOGRAPHIC METHOD FOR CIPROFLOXACIN BY QUALITY BY DESIGN APPROACH

Objective: The aim of this paper is to create a new, systematic high-performance thin-layer chromatography (HPTLC) method for ciprofloxacin that based on quality by design (QbD). Methods: mobile phase was chloroform: IPA: H2O: Formic Acid (2:7:0.5:0.5V/V), and the chromatographic separation performed aluminum-backed silica gel 60 F254 plates. Ciprofloxacin detected using UV light at 278nm. In factor screening studies, 3-factor 17-run standard 3-level factorial used, Box-Behnken used optimize HPTLC experimental parameters obtaining anticipated conditions. basic were tested understand risk assessment. Three independent parameters, such as saturation time, band duration, migration distance, chosen analyzed assessment see if these three influenced responses. For ciprofloxacin, produces compact well-resolved Rf = 0.40 0.02. linear regression analysis coefficient found be r2 0.996. Results: According International Council Harmonization (ICH) guidelines, it validated validation accuracy, precision, robustness, limit detection, quantification. proposed determination straightforward, precise, reliable, stable, sensitive. Conclusion: QbD produced more robust can generate accurate, high-quality, reliable data during process, effectively in routine inspection tablets dosage form.