氨基酸分析法测定复方骨肽注射液中多肽含量 - 中国药事.pdf

816 2011 25 8 田洪斌, 赵可意, 孙佳玲 ( , 130012) - 1 : 建立复方骨肽注射液中多肽含量的氨基酸分析法 氨基酸水解方法: 6mol # L 盐酸 110 e 水解22h; 氨基酸衍生方法: 异硫氰酸苯酯 ( PIT C) 法; HPLC 条 : Agilent E lipse AAA 色谱 - 1 柱; 流动相A: 01 1mol # L 乙酸钠 ( 用冰醋酸调至pH 61 5) -乙腈 ( 97 B 3) ; 流动相B: 乙腈- 水 ( 4 B - 1 1) ; 流速: 110mL # min ; 检测波长: 254nm 18 种氨基酸的线性精密度及稳定性良好; 除水解 样品中的胱氨酸与色氨酸外, 其他氨基酸的回收率均达到定量要求 方法准确专属性强, 可作为 复方骨肽注射液中多肽的定量分析方法 : 复方骨肽注射液; 氨基酸分析法; PIT C; HPLC : R92712 : A : 1002-7777 ( 20 11) 08-0816-05 Determination of Polypeptide in Compound Ossotide Injection by Amino Acid Analysis Tian Hongbin, Zhao Keyi and Sun Jialing ( Jilin Provin e Institute for Food and Drug Control, Chang hun 1300 12) ABSTRACT: Objective To determine the ontent of polypeptide in Compound Ossotide Inje tion by - 1 amino a id analy sis. Met ods Hy drolysis: 6mol # L HCl, 110 e , 22h. Derivation of amino a ids: PIT C. - 1 HPLC: Agilent E lipse AAA olumn. Mobile phase A: 01 1mol # L sodium a etate( adjust pH to 61 5 by gla ial a eti a id)-a etonitrile ( 97 B 3) , mobile phase B: a etonitrile-w ater ( 4 B 1) . T he dete tion - 1 w avelength w as at 254nm and the flow rate w as 110mL # min . Results T her e w ere good linear ity, pre ision and stability of 18 kinds of amino a id. The re overy of amino a ids meets the quantitative requirements ex ept ystine and tryptophane in hydroly sis analysis. Conclusion T he method is a ur ate and spe ifi , w hi h an be adoptable for q