| RP-HPLC法测定注射用重组人B淋巴细胞刺激因子受体-抗体融合蛋白的含量 |
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| 引用本文： | 姚雪静,李壮林. RP-HPLC法测定注射用重组人B淋巴细胞刺激因子受体-抗体融合蛋白的含量[J]. 中国药房, 2012, 0(33): 3144-3145 |
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| 作者姓名： | 姚雪静 李壮林 |
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| 作者单位： | 烟台荣昌生物工程有限公司,山东烟台264006 |
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| 摘 要： | 目的:建立测定注射用重组人B淋巴细胞刺激因子受体-抗体融合蛋白(简称TACI-Fc)含量的方法。方法:采用反相高效液相色谱法。色谱柱为VydacC18,流动相A液为含0.1%三氟乙酸的水溶液,流动相B液为含0.1%三氟乙酸的乙腈溶液,梯度洗脱,流速为1.3mL·min-1,检测波长为280nm。结果:TACI-Fc进样量在5.0～20.0μg范围内与峰面积积分值呈良好线性关系(r=0.9997);方法平均回收率为99.71%,RSD=1.14%(n=9)。结论:本方法操作简便、重复性好、结果准确,适用于测定注射用TA-CI-Fc的含量。
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| 关 键 词： | 反相高效液相色谱法 重组人B淋巴细胞刺激因子受体-抗体 融合蛋白 含量 |
Content Determination of Recombinant Human B Lymphocyte Stimulator Receptor-IgG Fc Fusion Protein for Injection by RP-HPLC |
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| YAO Xue-jing,LI Zhuang-lin. Content Determination of Recombinant Human B Lymphocyte Stimulator Receptor-IgG Fc Fusion Protein for Injection by RP-HPLC[J]. China Pharmacy, 2012, 0(33): 3144-3145 |
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| Authors: | YAO Xue-jing LI Zhuang-lin |
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| Affiliation: | (Yantai RC Biotechnologies,Co.,Ltd.,Shandong Yantai 264006,China) |
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| Abstract: | OBJECTIVE：To establish the method for the content determination of recombinant human B lymphocyte stimulator receptor-IgG Fc fusion protein（TACI-Fc） for injection.METHODS：RP-HPLC method was adopted.The chromatographic column was Vydac C18 column with 0.1% trifluoroacetic acid in water as mobile phase A and 0.1% trifluoroacetic acid in acetonitrile as mobile phase B（gradient elution） at the flow rate of 1.3 mL·min-1.The detection wavelength was set at 280 nm.RESULTS：The linear range of TACI-Fc was 5.0～20.0 μg（r=0.999 7） with an average recovery of 99.71%（RSD=1.14%,n=9）.CONCLUSION：The method is simple,reproducible and accurate for the content determination of TACI-Fc for injection. |
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| Keywords: | RP-HPLC Recombinant human B lymphocyte stimulator receptor-IgG Fc Fusion protein Content |
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