HPLC法测定盐酸表阿霉素-索拉非尼PLGA栓塞微球的载药量和包封产率

发布时间：2018-09-14 09:49

【摘要】：目的:建立测定盐酸表阿霉素-索拉非尼聚乳酸-羟基乙酸聚合物(PLGA)栓塞微球载药量和包封产率的方法。方法:采用高效液相色谱法测定该制剂中盐酸表阿霉素和索拉非尼的含量,再通过公式计算载药量和包封产率。色谱柱为Phenomenex Luna 5u C8(2)100A,流动相为甲醇-[水(含0.05%三氟乙酸和0.14%十二烷基硫酸钠)](75∶25,V/V),流速为1.0 mL/min,检测波长为252 nm,柱温为25℃,进样量为10μL。结果:盐酸表阿霉素和索拉非尼检测质量浓度线性范围分别为2.020~101.00μg/mL(r=0.999 8)、2.048~102.40μg/mL(r=0.999 7);定量限分别为3.297 0、2.546 8μg/mL;检测限分别为0.989 1、0.764 1μg/mL;精密度、稳定性、重复性试验的RSD2.0%;回收率分别为96.41%~101.80%(RSD=1.64%,n=9)、99.46%~101.45%(RSD=0.70%,n=9)。3批样品中两种成分的载药量≥1.17%,包封产率≥58%。结论:该方法操作简单、结果准确,可用于测定盐酸表阿霉素-索拉非尼PLGA栓塞微球的载药量和包封产率。
[Abstract]:Aim: to establish a method for the determination of drug loading and encapsulation yield of epirubicin-Solafenil-poly (lactic acid)-glycolic acid polymer (PLGA) for embolization of microspheres. Methods: the contents of epirubicin hydrochloride and sorafenil in the preparation were determined by HPLC, and the drug loading and encapsulation yield were calculated by formula. The chromatographic column was Phenomenex Luna 5u C8 (2) 100A, the mobile phase was methanol-water (containing 0.05% trifluoroacetic acid and 0.14% sodium dodecyl sulfate) (75: 25 V / V), the flow rate was 1.0 mL/min, the detection wavelength was 252UC8 (2) 100A, and the sample size was 10 渭 L at 25 鈩，

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