Development and validation of a UV spectrophotometric method for measuring ciprofloxacin hydrochloride in chitosan films used for orthopedic implants coatings

A simple, precise, and accurate ultraviolet-visible (UV-Vis) spectrophotometric method was developed and validated to quantify ciprofloxacin hydrochloride (CIP.HCl) in chitosan films for coating orthopedic implants. Methods were developed to enable quantification in both acidic and basic conditions. The validation parameters were established according to the Resolution of the Collegiate Board (RDC) No. 166, of July 24, 2017, of the Brazilian National Health Regulatory Agency (ANVISA). Samples with CIP.HCl exhibited maximum absorption at 277 nm in acidic medium and 271 nm in basic medium. Linearity was achieved in the concentration range of 2–10 μg mL–1 with a correlation coefficient 0.999 and statistical significance. The relative standard deviation for precision was ≤ 2%. Recovery percentages of the analyte in the films exceeded 98.0%. No matrix effect was identified, and the method demonstrated robustness. The detection limit was 0.11 µg mL–1 for acidic and 0.21 µg mL–1 for basic conditions, while the quantification limit was 0.34 μg mL–1 for acidic and 0.64 µg mL–1 for basic pH.