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为测定PELA微粒中胰岛素含量,建立反相高效液相色谱方法.以Zorbax300SB C18高效液相色谱柱分离;检测波长为220nm;流动相组成为:V(H2O(含φ(TFA)=0.15%))∶V(CH3CN)=66∶34;保留时间为4.3min.结果在ρ(胰岛素)为10～200μg/mL范围内,峰面积(A)与胰岛素质量浓度(ρ)成线性变化,其线性方程为:ρ=7.82×10-2A+9.88×10-2,相关系数r=0.99995.日内差和日间差分别为0.6%和0.7%.当ρ(胰岛素)为60,80和100μg/mL时的回收率分别为(98.1±0.5)%,(99.6±1.5)%和(99.4±1.0)%(n=6).测得胰岛素在PELA微粒中的包封率为(56.3±3.3)%(n=6).
To determine the content of insulin in PELA microparticles, an RP-HPLC method was established, which was separated on a Zorbax 300SB C18 high performance liquid chromatographic column with a detection wavelength of 220 nm. The mobile phase consisted of V (H2O (containing TFA = 0.15% ): V (CH3CN) = 66:34, and the retention time was 4.3 min.RESULTS The peak area (A) and the insulin concentration (ρ) changed linearly in the range of ρ (insulin) of 10 ~ 200 μg / The equation is: ρ = 7.82 × 10-2A + 9.88 × 10-2, the correlation coefficient r = 0.99995. Intraday difference and daytime difference are 0.6% and 0.7% respectively. When ρ (insulin) is 60, 80 and 100μg / mL (98.1 ± 0.5)%, (99.6 ± 1.5)% and (99.4 ± 1.0)% (n = 6) respectively.The entrapment efficiency of insulin in PELA microparticles was (56.3 ± 3.3)% (n = 6).