Dana Haj-Ali, Hanan Azzam, Khaled Aiedeh, Walhan Alshaer
Background A rapid, simple, accurate, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed to quantify curcumin and dexamethasone in polymeric micelle nanoparticle formulations simultaneously.Methods The optimized chromatographic conditions involved a Universal HS C18 column, isocratic elution with a methanol: acidic water (pH 3.5, 80:20, v/v) mobile phase, and detection wavelengths of 425 nm for curcumin and 254 nm for dexamethasone. The developed method was subsequently validated according to ICH guidelines, and demonstrated excellent linearity (R2 > 0.999), precision (RSD% < 2%), and accuracy (mean recovery was 98.7% for curcumin and 101.7% for dexamethasone).Results The limits of detection (LOD) were 0.0035 mg/mL for curcumin and 0.0029 mg/mL for dexamethasone, while limits of quantification (LOQ) were 0.0106 mg/mL for curcumin and 0.0088 mg/mL for dexamethasone, respectively. The method was applied to evaluate the encapsulation efficiency (EE%) of curcumin and dexamethasone into polymeric micelle nanoparticles formulated using Soluplus® and DOPE in a 1:10 molar ratio. EE% values were 78.84 ± 0.05% for curcumin and 54.33 ± 0.05% for dexamethasone.Conclusions the current developed method indicates suitability for the simultaneous determination of curcumin and dexamethasone, thereby facilitating the quality control and optimization of such advanced drug delivery systems.