OBJECTIVE: To establish the method for the determination of main components in Misonidazole pH-sensitive liposome. METHODS: The phosphatidylethanolamine in Misonidazole pH-sensitive liposomes was removed by metal ion precipitation method (using ZnCl2 as the metal ion precipitating agent). The content of main components was determined by UV spectrometry (at the wavelength of 322 nm), and then compared with the results of HPLC method [Hypersil C18, mobile phase consisted of methanol-water (20 ∶ 80, V/V), flow rate of 1.0 mL/min, detection wavelength of 322 nm, column temperature of 30 ℃, sample size of 20 μL]. RESULTS: The linear range of misonidazole were 0.96-30.72 μg/mL (r=0.999 6) and 0.48-4.80 μg/mL (r=0.999 5) by two methods. RSDs of precision, stability and reproducibility tests were all lower than 2%. The recovery rates were 97.23%-102.33% (RSD=1.05%,n=9) and 97.35%-99.75% (RSD=1.15%,n=9). The contents were 99.86%, 100.16%, 100.32% and 99.95%, 99.98%, 100.05%. CONCLUSIONS: UV method combined with metal ion precipitation method is simple, accurate, species, stable, and reproducible. It can be used for the determination of misonidazole content in misonidazole pH-sensitive liposome. The result is in agreement with those determined by HPLC.
关键词
米索硝唑pH敏感脂质体紫外分光光度法高效液相色谱法金属离子沉淀法含量测定
Keywords
MisonidazolepH-sensitive liposomeUV spectrometryHPLCMetal ion precipitation methodContent determination