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目的:建立尼莫地平脂质体药物含量测定及包封率测定的RP-HPLC法。方法:采用Hypersil ODS柱(250mm×4.6mm,5μm);流动相:甲醇-水-四氢呋喃(40:30:30);柱温:30℃;流速:1mL·min~(-1) ;紫外检测波长:237nm。采用透析法分离尼莫地平脂质体中的游离药物。结果:在本色谱条件下尼莫地平与辅料及溶剂峰分离良好,尼莫地平在0.2～45μg·mL~(-1)范围内线性关系良好(r=0.999 9,n=5),回收率在99.90％～102.0％之间,日内RSD及日间RSD均小于3％(n=5)。结论:说明该方法准确可靠、简单快速,可用于尼莫地平纳米脂质体含量及包封率的测定。
Objective: To establish a method for the determination of nimodipine liposomes and determination of entrapment efficiency by RP-HPLC. Methods: Hypersil ODS column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol - water - tetrahydrofuran (40:30:30). The column temperature was 30 ℃ and the flow rate was 1 mL · min -1. Wavelength: 237nm. Dialysis was used to separate free drug in nimodipine liposomes. Results: The separation of nimodipine and its excipients and solvent peaks was good under the chromatographic conditions. The linear relationship between nimodipine and 0.2 ~ 45μg · mL ~ (-1) was good (r = 0.999 9, n = 5) Between 99.90% and 102.0%, intraday RSD and daytime RSD were all less than 3% (n = 5). Conclusion: This method is accurate and reliable, simple and rapid, and can be used for the determination of the content of nano-liposomes and encapsulation efficiency of nimodipine.