Pharmaceutical and Biomedical Research

en A Simple, Accurate, and Cost-Effective HPLC-UV Method for Determination of Nanoliposome Components as Drug Carriers آنالیز دارو Drug Analysis پژوهشي Original Research Background: Nanoliposomes are extensively employed as drug delivery systems owing to their excellent biocompatibility, biodegradability, and ability to enhance drug stability and targeted delivery. Accurate determination of lipid components in nanoliposomal formulations is essential for quality control, stability assessment, and regulatory compliance; however, simultaneous analysis of structurally similar lipids remains analytically challenging. Objectives: This study aimed to develop and validate a simple, accurate, and cost-effective high-performance liquid chromatography coupled with ultraviolet detection (HPLC–UV) method for the simultaneous determination of α-(3-O-cholesteryloxy)-δ-(N-ethylmorpholine)-succineamide (MoChol), cholesteryl hemisuccinate (Chems), cholesterol, dioleoyl-phosphatidylethanolamine (DOPE), and palmitoyl-oleoylphosphatidylcholine (POPC) in nanoliposome formulations containing anti-BCL-2 DNA oligonucleotides. Methods: Chromatographic separation was performed on a C18 column using a gradient elution system consisting of 0.1% trifluoroacetic acid in water and 0.1% trifluoroacetic acid in ethanol as mobile phases. Detection was carried out at 202 nm with a flow rate of 1.0 mL min⁻¹. The method was validated according to ICH guidelines with respect to linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), and limit of quantification (LOQ). Results: Excellent linearity was obtained for all analytes over concentration ranges of 1–2134 mg L⁻¹ with correlation coefficients (R²) greater than 0.9997. The LOD and LOQ values ranged from 0.13–0.23 mg L⁻¹ and 0.39–0.69 mg L⁻¹, respectively. Recovery values were within 98–102%, while precision expressed as relative standard deviation was below 1%. Resolution values exceeded 2.0 for all critical peak pairs, demonstrating adequate specificity. The method was successfully applied to evaluate lipid composition in nanoliposome samples and to monitor compositional changes after long-term storage. Conclusions: The developed HPLC–UV method provides a reliable, sensitive, and economical approach for the simultaneous determination of major lipid components in nanoliposomal drug delivery systems. Its satisfactory validation performance and applicability to stability studies make it suitable for routine quality control and pharmaceutical development of lipid-based formulations.   Nanoliposomes, Drug Carrier, Lipid Analysis, High performance liquid chromatography HPLC, Method Development 0 0 http://pbr.mazums.ac.ir/browse.php?a_code=A-10-1473-1&slc_lang=en&sid=1 Abolghasem Beheshti ag.beheshti@gmail.com 100319475328460012359 100319475328460012359 Yes Department of Chemistry, Payame Noor University, P. O. Box 19395-3697, Tehran, Iran Mehdi Tavakoli mehdi136@gmail.com 100319475328460012360 100319475328460012360 No 2Quality Control Lab, Tofigh Daru Research and Engineering Co, Tehran, Iran mahmood payeghadr mpayehghadr@pnu.ac.ir 100319475328460012361 100319475328460012361 No Department of Chemistry, Payame Noor University, P. O. Box 19395-3697, Tehran, Iran vahid karbasi ahid.seyedali0990@gmail.com 100319475328460012362 100319475328460012362 No 2Quality Control Lab, Tofigh Daru Research and Engineering Co, Tehran, Iran