| RP-HPLC法测定聚乙二醇重组人促红素成品中甲硫氨酸的含量 |
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| 引用本文： | 庞甲佩,胥国立,解福生,赵婷婷,马立平. RP-HPLC法测定聚乙二醇重组人促红素成品中甲硫氨酸的含量[J]. 齐鲁药事, 2013, 0(12): 686-687,704 |
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| 作者姓名： | 庞甲佩 胥国立 解福生 赵婷婷 马立平 |
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| 作者单位： | [1]山东阿华生物药业有限公司,山东东阿252201 [2]山东东阿阿胶股份有限公司,山东东阿252201 |
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| 基金项目： | 国家重大新药创制专项（No.2012ZX09202-031-004） |
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| 摘 要： | 目的建立聚乙二醇重组人促红素(PEG-EPO)成品中甲硫氨酸含量测定的方法。方法采用反相高效液相色谱法,色谱柱为Waters Symmetry C18(4.6 mm×250 mm,5μm),流动相A为注射用水,B为乙腈。检测波长为210 nm,流速为1.0 mL·min-1。结果甲硫氨酸进样量在11.1933.57μg范围内,线性关系良好(r=0.999 5);该方法的平均回收率为100.38%,RSD为0.95%(n=5)。结论所建立的方法简单、精密度、准确度良好,可用于PEG-EPO成品中甲硫氨酸含量测定。
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| 关 键 词： | 聚乙二醇重组人促红素 甲硫氨酸 反相高效液相色谱 |
Determination of methionine in PEG-EPO by RP-HPLC |
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| PANG Jia-pei,XU Guo-li,XIE Fu-sheng,ZHAO Ting-ting,MA Li-ping. Determination of methionine in PEG-EPO by RP-HPLC[J]. qilu pharmaceutical affairs, 2013, 0(12): 686-687,704 |
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| Authors: | PANG Jia-pei XU Guo-li XIE Fu-sheng ZHAO Ting-ting MA Li-ping |
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| Affiliation: | 1. Shandong E - Hua Biopharmaceutical Co. , Ltd. , Donge 252201, China ; 2. Shandong Dong - E E - Jiao Co. , Ltd. , Donge 252201, China ) |
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| Abstract: | Objective To establish a method for determining methionine in PEG - EPO. Methods Quantification was performal by RP -HPLC waters synmtry C18 column（4.6 mm×250 mm,5 μm） ,water for injection was applied as mobile A,acetonitrile as molile B,detected at 210 nm. The flow rate was 1.0 mL . min -1. Results The linear range was good in 11.19 - 33.57 μg（ r = 0. 999 5 ）. The average recovery was 100. 38% , and the RSD was 0.95%. Conclusion The estab- lished method was simple, high sensitive and accurate with a high reproducibility and can be used for the determination of methionine PEG - EPO. |
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| Keywords: | PEG - EPO Methionine RP - HPLC |
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