Department of Pharmaceutics, Delhi Pharmaceutical Sciences and Research University, Delhi 110017, India
Amphotericin B (AmB) is a potent antifungal agent whose clinical use is limited by poor aqueous solubility and high lipophilicity, making lipid nanoparticles a promising delivery platform. The present study aimed to establish a comprehensive preformulation profile of AmB relevant to lipid nanoparticle development and to develop and validate a sensitive HPLC method for its quantitative analysis. Preformulation studies including drug identification, melting point determination, saturation solubility studies in aqueous, organic, and solid lipid matrices, and determination of the partition coefficient were performed. AmB exhibited extremely low aqueous solubility, significantly higher solubility in lipid media, and a high partition coefficient with a log P value of approximately 4.6, confirming its strong affinity for lipid-based carriers. An HPLC method was successfully developed and optimized by appropriate selection of mobile phase composition, flow rate, and detection wavelength, producing a sharp and well-resolved AmB peak with a retention time of 5.9 min. The method showed excellent linearity over the studied concentration range with a correlation coefficient (R²) greater than 0.999. The limit of detection (LOD) and limit of quantitation (LOQ) were found to be 0.04 µg/mL and 0.12 µg/mL, respectively, demonstrating high analytical sensitivity. System suitability parameters were within acceptable limits, confirming method reliability. FT-IR compatibility studies revealed no significant interactions between AmB and selected lipid excipients. Overall, these findings provided strong preformulation and analytical support for the rational development of AmB loaded lipid nanoparticles.
Keywords: Amphotericin B; Lipid nanoparticles; Preformulation studies; HPLC method development; Method validation
How to cite this article: Jain V K, Popli H, Preformulation Studies of Amphotericin B for Formulation and Development of Lipid Nanoparticles for Macrophage Targeted Delivery. Int J Drug Deliv Technol. 2026;16(6s): 370-383; DOI: 10.25258/ijddt.16.6s.39
Source of support: Nil
Conflict of interest: None