RP-HPLC法测定降血压肽/聚乳酸-羟基乙酸微球中主药含量及包封率

目的:建立测定降血压肽(AHP)/聚乳酸-羟基乙酸(PLGA)微球中AHP含量和包封率的反相高效液相色谱(RP-HPLC)法。方法:样品经二氯甲烷破坏并用水萃取后进行测定。反相色谱柱为Eclipse XDB-C18,流动相为乙腈-水(含0.05%三氟乙峰酸)均=得1到7∶很83好,流的速分为离1,.0A mHPL.检m测in浓-1,度柱线温性为范30围℃为,2检5～测6波25长μ为g.1m9L9-n(1mr,=进0样.99量9为9),2平0μ均L回。收结率果为:在9此8.7色8%谱,条日件内下和A日H间P与精辅密料度及分溶别为剂0.53%、0.86%(n=5)。结论:所建立的方法操作简单、快速,结果准确、可靠,可用于AHP/PLGA微球中主药含量及包封率的测定。

Determination of Main Components in AHP/PLGA Microspheres by RP-HPLC and Its Encapsulation Efficiency

OBJECTIVE： To establish RP-HPLC method for the content determination of AHP and encapsulation efficacy detection in AHP/PLGA microsphere.METHODS： The microspheres were dissolved by methylene dichloride,and the drug encapsulated in the microspheres could be extracted by water.The separation was performed on Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-water（0.05%TFA）（17 ∶ 83） at flow rate of 1.0 mL·min^-1.The detection wavelength was set at 199 nm and column temperature was 30 ℃.Injection volume was 20 μL.RESULTS： AHP was well-separated from other components.The linear range of AHP was 25～625 μg·mL^-1（r=0.999 9） with an average recovery of 98.78%.The RSD of intra-day and inter-day were 0.53% and 0.86%（n=5）.CONCLUSION： The method is simple,rapid,accurate and reliable for the content determination and encapsulation efficacy detection of AHP/PLGA microspheres.