[Study on determination method for components in monocrotalinum liposomes and their entrapment efficiency]

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Drug Delivery Systems

Background:

• Accurate quantification of active pharmaceutical ingredients (APIs) within liposomal formulations is essential for ensuring therapeutic efficacy and safety.
• Liposomes are widely used drug delivery systems, requiring robust analytical methods for quality control.
• Existing methods may lack the precision or feasibility for routine analysis of liposomal components and entrapment efficiency.

Purpose of the Study:

• To develop and validate a High-Performance Liquid Chromatography (HPLC) method for determining components within monocrotalinum liposomes.
• To establish and validate a microcolumn centrifugation method for assessing the entrapment efficiency of monocrotalinum liposomes.
• To provide reliable analytical tools for the quality control of monocrotalinum liposomal formulations.

Main Methods:

• High-Performance Liquid Chromatography (HPLC) was employed to determine the concentration of components in monocrotalinum liposomes.
• Method validation included assessment of linearity, precision (intra-day and inter-day), stability, reproducibility, and recovery rate.
• Microcolumn centrifugation was utilized to determine the entrapment efficiency, with validation parameters including recovery rate and blank liposome recovery.

Main Results:

• The HPLC method demonstrated excellent linearity (r = 0.9998) within the 1.6-102.4 mg/L range, with low relative standard deviations (RSDs) for precision (intra-day: 0.61%, inter-day: 0.92%) and reproducibility (1.6%).
• The recovery rate for monocrotaline using HPLC was high at 99.96% ± 0.50%.
• The microcolumn centrifugation method showed high recovery rates (94.44% ± 0.77% for components, 95.86% ± 0.68% for blank liposomes) and low RSD (4.0%) for entrapment efficiency determination in monocrotaline liposomes.

Conclusions:

• The established HPLC method provides an accurate and reliable means for quantifying components in monocrotalinum liposomes.
• The microcolumn centrifugation method is an accurate and feasible technique for determining the entrapment efficiency of monocrotaline liposomes.
• These validated analytical methods are suitable for the quality control and characterization of monocrotalinum liposomal formulations.