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

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Nanotechnology

Background:

• Ivermectin (IVM) faces limitations in clinical use due to poor solubility and stability.
• Polymeric nanocapsules offer a potential solution for enhancing IVM delivery.
• Accurate quantification of IVM within nanocarriers is crucial for formulation development.

Purpose of the Study:

• To develop and validate a selective reversed-phase HPLC-DAD method for ivermectin quantification.
• To apply the method for analyzing ivermectin in polymeric nanocapsules.
• To assess encapsulation efficiency and preliminary chemical stability of ivermectin in nanocarriers.

Main Methods:

• Reversed-phase High-Performance Liquid Chromatography with Diode-Array Detection (HPLC-DAD) on a C18 column.
• Isocratic elution using acetonitrile and purified water (90:10, v/v).
• Method validation following ICH Q2-(R2) guidelines, including linearity, accuracy, precision, and selectivity.

Main Results:

• The HPLC-DAD method demonstrated excellent linearity (R² > 0.99), accuracy (near 100% recovery), and precision (RSD < 2%).
• High encapsulation efficiency of ivermectin within polymeric nanocapsules was achieved.
• Preliminary stability studies showed ivermectin content remained above 95% over 30 days.

Conclusions:

• The developed HPLC-DAD method is simple, selective, accurate, and robust for quantifying ivermectin in complex nanostructured formulations.
• This analytical tool supports the development of improved ivermectin-based nanomedicines.
• The method facilitates reliable assessment of nanocarrier performance and drug stability.