Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION STRATEGIES FOR LEVOFLOXACIN: A COMPREHENSIVE REVIEW

Miss Kiran Chavan*, Dr. Swapnil Nazarkar

Abstract

Levofloxacin is a broad-spectrum fluoroquinolone antibiotic widely used in the treatment of respiratory tract infections, urinary tract infections, gastrointestinal infections, and skin infections. Due to its extensive therapeutic applications and the increasing need for quality assurance in pharmaceutical industries, the development of reliable analytical methods for its estimation has become highly important. Reverse Phase High Performance Liquid Chromatography (RP-HPLC) remains one of the most preferred analytical techniques for the quantitative estimation of Levofloxacin because of its accuracy, precision, sensitivity, and reproducibility. In recent years, the implementation of Quality by Design (QbD) principles in analytical method development has significantly improved method robustness, regulatory compliance, and analytical reliability. This review highlights recent advancements in RP-HPLC analytical methods developed for Levofloxacin with special emphasis on QbD-assisted optimization approaches. The review discusses physicochemical properties, pharmacological importance, chromatographic conditions, analytical method validation parameters, Design of Experiments (DoE), risk assessment tools, robustness studies, and future perspectives in pharmaceutical analytical sciences. The article also summarizes ICH regulatory guidelines associated with analytical method development and validation. The findings indicate that QbD-driven HPLC provide superior reproducibility, better understanding of critical method parameters, reduced variability, and enhanced lifecycle management compared to conventional approaches.

Keywords: Levofloxacin, RP-HPLC, Quality by Design, QbD, Method Validation, Analytical Method Development, ICH Guidelines, Pharmaceutical Analysis.