复旦学报(自然科学版)
複旦學報(自然科學版)
복단학보(자연과학판)
JOURNAL OF FUDAN UNIVERSITY(NATURAL SCIENCE)
2003年
4期
638-642
,共5页
反相高效液相色谱%定量分析%胰岛素%PELA%微粒
反相高效液相色譜%定量分析%胰島素%PELA%微粒
반상고효액상색보%정량분석%이도소%PELA%미립
RP-HPLC%quantitative analysis%insulin%PELA%microparticles
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220 nm;流动相组成为:V(H2O(含φ(TFA)＝0.15%))∶V(CH3CN)＝66∶34;保留时间为4.3 min. 结果在ρ(胰岛素)为10～200 μg/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=0.999 95. 日内差和日间差分别为0.6%和0.7%. 当ρ(胰岛素)为60, 80和100 μg/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).
為測定PELA微粒中胰島素含量,建立反相高效液相色譜方法. 以Zorbax300SB-C18高效液相色譜柱分離;檢測波長為220 nm;流動相組成為:V(H2O(含φ(TFA)＝0.15%))∶V(CH3CN)＝66∶34;保留時間為4.3 min. 結果在ρ(胰島素)為10～200 μg/mL範圍內,峰麵積(A)與胰島素質量濃度(ρ)成線性變化,其線性方程為:ρ=7.82×10-2A +9.88×10-2,相關繫數r=0.999 95. 日內差和日間差分彆為0.6%和0.7%. 噹ρ(胰島素)為60, 80和100 μg/mL時的迴收率分彆為(98.1±0.5)%, (99.6±1.5)%和(99.4±1.0)%(n＝6). 測得胰島素在PELA微粒中的包封率為(56.3±3.3)%(n＝6).
위측정PELA미립중이도소함량,건립반상고효액상색보방법. 이Zorbax300SB-C18고효액상색보주분리;검측파장위220 nm;류동상조성위:V(H2O(함φ(TFA)＝0.15%))∶V(CH3CN)＝66∶34;보류시간위4.3 min. 결과재ρ(이도소)위10～200 μg/mL범위내,봉면적(A)여이도소질량농도(ρ)성선성변화,기선성방정위:ρ=7.82×10-2A +9.88×10-2,상관계수r=0.999 95. 일내차화일간차분별위0.6%화0.7%. 당ρ(이도소)위60, 80화100 μg/mL시적회수솔분별위(98.1±0.5)%, (99.6±1.5)%화(99.4±1.0)%(n＝6). 측득이도소재PELA미립중적포봉솔위(56.3±3.3)%(n＝6).
A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for determination of insulin encapsulated in PELA microparticles. Zorbax 300SB-C18 RP-HPLC column was employed with UV detection at 220 nm. Trifluroacetic acid (TFA) was added into mobile phase to improve separate effect. The composition of the mobile phase was V(H2O(φ(TFA)=0.15%))∶V(CH3CN)=66∶34. The retention time of insulin was 4.3 min. Mass concentration (ρ) and peak area (A) had linearity from 10 to 200 μg/mL and the linear equation was ρ=7.82×10-2A+ 9.88×10-2 with correlation coefficient r=0.999 95. The intra- and inter-day relative standard deviations (RSDs) were 0.6% and 0.7%, respectively. The average recoveries (mean±SD) of the three groups (ρ(insulin) =60, 80, 100 μg/mL, respectively) were (98.1±0.5)%, (99.6±1.5)% and (99.4±1.0)%, respectively (n=6). The encapsulation efficiency (mean±SD) of insulin was (56.3±3.3)% (n=6).
