Abstract

PREFORMULATION STUDIES AND ANALYTICAL METHOD DEVELOPMENT FOR ENROFLOXACIN AND CIPROFLOXACIN: A QUALITY CONTROL APPROACH

Mohd. Mazhar Mansuri*, Ravi Prakash, Sheenam Mansuri, Praveen Bhawsar, Brajesh Ku. Arjariya

Abstract

Objective: To evaluate the preformulation properties of Enrofloxacin and Ciprofloxacin, including organoleptic, solubility, melting point, pH, FTIR spectra, and linearity, and to establish precise analytical methods for quality control. Methods: The drugs were characterized for solubility in various solvents, pH, melting point, and FTIR spectra. Linearity, precision, ruggedness, robustness, and recovery studies were conducted using UV-Vis spectrophotometry. Regression equations and correlation coefficients were determined, and LOD and LOQ values were calculated. Results: Enrofloxacin and Ciprofloxacin exhibited distinct solubility profiles and melting points (220°C and 235°C). The pH values were 7.34 and 3.81, respectively. FTIR analysis confirmed characteristic functional groups. Linearity was observed over concentration ranges of 2-10 μg/mL (Enrofloxacin) and 10-50 μg/mL (Ciprofloxacin) with high correlation coefficients (R² = 0.9973 and 0.9975). Precision and ruggedness were within acceptable limits, and recovery rates were 98-99.9%. Conclusion: The proposed analytical method is simple, precise, and robust, making it suitable for the quality control of Enrofloxacin and Ciprofloxacin in pharmaceutical formulations.

Keywords: Enrofloxacin, Ciprofloxacin, Preformulation, UV-Vis Spectrophotometry, Linearity, FTIR.