摘要
目的建立复方骨肽注射液中多肽含量的氨基酸分析法。方法氨基酸水解方法:6mol.L-1盐酸110℃水解22h;氨基酸衍生方法:异硫氰酸苯酯(PITC)法;HPLC条件:Agilent Eclipse AAA色谱柱;流动相A:0.1mol.L-1乙酸钠(用冰醋酸调至pH 6.5)-乙腈(97∶3);流动相B:乙腈-水(4∶1);流速:1.0mL.min-1;检测波长:254nm。结果 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。结论方法准确、专属性强,可作为复方骨肽注射液中多肽的定量分析方法。
Objective To determine the content of polypeptide in Compound Ossotide Injection by amino acid analysis.Methods Hydrolysis： 6mol·L-1 HCl,110℃,22h.Derivation of amino acids： PITC.HPLC： Agilent Eclipse AAA column.Mobile phase A： 0.1mol·L-1sodium acetate（adjust pH to 6.5 by glacial acetic acid）-acetonitrile（97∶3）,mobile phase B： acetonitrile-water（4∶1）.The detection wavelength was at 254nm and the flow rate was 1.0mL·min-1.Results There were good linearity,precision and stability of 18 kinds of amino acid.The recovery of amino acids meets the quantitative requirements except cystine and tryptophane in hydrolysis analysis.Conclusion The method is accurate and specific,which can be adoptable for quantitative analysis of polypeptide in Compound Ossotide Injection.
出处
《中国药事》
CAS
2011年第8期816-820,共5页
Chinese Pharmaceutical Affairs
