Analytical Validation of an HPLC–DAD Method for Ivermectin Quantification in Polymeric Nanocapsules

High Resolution Image Download MS PowerPoint Slide Ivermectin (IVM) is a broad-spectrum antiparasitic drug whose clinical application is limited by poor aqueous solubility, chemical instability, and pharmacokinetic variability. Polymeric nanocapsules represent a promising strategy to overcome these limitations. However, their complex composition requires reliable and selective analytical methods for accurate drug quantification. In this study, a reversed-phase HPLC–DAD method was developed and validated for the quantification of ivermectin and applied to polymeric nanocapsules, including the determination of encapsulation efficiency and drug loading. Chromatographic separation was achieved on a C18 column using isocratic elution with acetonitrile and purified water (90:10, v/v) with diode-array detection at 253 nm and a retention time of approximately 4.7 min. The method was validated according to ICH Q2(R2) guidelines, demonstrating adequate selectivity through evaluation of matrix interference and analysis under stress conditions. Linearity was observed over the analytical range (R 2 > 0.99), while accuracy and precision were satisfactory, with recovery values close to 100% and relative standard deviation below 2%. Application of the method to polymeric nanocapsules resulted in high encapsulation efficiency. A preliminary evaluation of chemical stability over 30 days indicated that ivermectin content remained above 95% under the evaluated storage conditions. Overall, the proposed method is simple, selective, precise, accurate, robust, and suitable for the quantitative analysis of ivermectin in complex nanostructured formulations.