Application of quality by design approach in HPLC-UV validation of ciprofloxacin in porcine ocular tissue and simulated ocular fluid for quantification in an ex vivo ocular kinetic study

Abstract

We present a novel high-performance liquid chromatographic method (HPLC-UV) for quantifying ciprofloxacin after ex vivo administration. The procedure was developed and validated in accordance with ICH and FDA guidelines, and it was successfully used to determine the concentration of ciprofloxacin. Analytical quality by design (AQbD) was used to develop extraction techniques and optimize HPLC conditions. Ciprofloxacin was efficiently extracted through a single-step protein precipitation and extraction procedure, with a 94.32 ± 0.61% recovery rate. All analytes were separated using isocratic elution and a mobile phase acetonitrile and disodium hydrogen phosphate over a 10-min run period. The validated method was discovered to be selective, precise, and accurate. Finally, using the method developed in this study, the drug's ocular kinetic profiles were determined following ex vivo administration of eye drops and ointment. This validated HPLC-UV approach has potential applications in ocularcokinetics research.