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目的制备琥珀布考纳米胶束,建立琥珀布考纳米制剂的HPLC含量测定方法,并用于其含量的测定。方法采用滴入法制备琥珀布考纳米胶束,应用高效液相色谱法测定药物含量。色谱柱为Discovery-C18 HS F5-5柱(250 mm×4.6 mm,5μm),流动相为乙腈-体积分数0.1%TFA水溶液(体积比80:20),流速为1.0 m L·min-1,检测波长为242 nm,进样量为20μL。采用高速离心法分离纳米胶束与游离药物并测定其包封率和载药量。结果琥珀布考质量浓度在1.0~500.0 mg·L-1内与吸收峰面积呈良好的线性关系,回归方程为A=1.920 3×104ρ+2.424 6×104(r=1.000 0),低、中、高三个质量浓度的回收率均在98%~102%,日内精密度和日间精密度的RSD均小于2%(n=6)。自制琥珀布考纳米制剂的含量为(3.88±0.06)g·L-1,包封率为(96.95±0.02)%,载药量为(9.65±0.01)%。结论该方法准确可靠、简单快速、重复性好,可用于测定琥珀布考纳米制剂的含量、包封率和载药量。
OBJECTIVE To prepare amber cloth nanoparticle micelles and to establish a HPLC method for the determination of amber cloth test nanoemulsion and to determine its content. Methods Amber cloth nanoparticles micelles were prepared by dropping method. The content of drug was determined by HPLC. The column was a Discovery-C18 HS F5-5 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-0.1% TFA in water with a volumetric ratio of 80:20 and a flow rate of 1.0 mL · min -1. The detection wavelength was 242 nm and the injection volume was 20 μL. Nanophase micelles and free drug were separated by high-speed centrifugation and their entrapment efficiency and drug loading were measured. Results The concentration of amber cloth test showed a good linear relationship with the absorption peak area in 1.0 ~ 500.0 mg · L-1. The regression equation was A = 1.920 3 × 104ρ + 2.424 6 × 104 (r = 1.000 0) , And the recoveries of high and low concentration were 98% -102%. The intraday RSD and intraday precision RSD were less than 2% (n = 6). The content of homemade amber cloth preparation was (3.88 ± 0.06) g · L-1, the encapsulation efficiency was (96.95 ± 0.02)% and the drug loading was (9.65 ± 0.01)%. Conclusion The method is accurate, reliable, simple, rapid and reproducible. It can be used to determine the content, entrapment efficiency and drug loading of amber cloth preparations.