中国药房2011，Vol.22Issue(25)：2374-2376,3.
HPLC法测定甲状旁腺激素1-34原料药中有关物质的含量
Content Determination of Related Substances in PTH 1-34 Crude Drugs by HPLC
余邦良 1杨柳 1王秀玲2
作者信息
- 1. 海南医学院药学院,海口市571101
- 2. 海南紫杉园药业有限公司,海口市570216
- 折叠
摘要
Abstract
OBJECTIVE: To establish a method for the content determination of related substances in PTH 1-34 crude drugs. METHODS: HPLC method was adopted. The determination was performed on Kromasil d18 column. The mobile phase consisted of 0.05 mol·L-1 potassium chloride water solution (pH adjusted to 4.5 using phosphoric acid)-acetonitrile (75:25). The flow rate was 1.0 mL·min-1 and the detection wavelength was set at 210 nm. Column temperature was room temperature and injection volume was 20 uL. The contents of related substances in PTH 1-34 were calculated by self-control method of main constituent. RESULTS: Under the above described chromatographic conditions, PTH 1-34 was completely separated from its impurities. The linear range of related substances was 5~50 μg·mL-1 (r=0.999 96). The contents of related substances in PTH 1-34 were all less than 0.29%. CONCLUSION: The method is convenient, accurate, sensitive and specific, and it is suitable for the content determination of related substances in PTH 1-34 crude drugs.关键词
高效液相色谱法/甲状旁腺激素1-34/原料药/有关物质/含量Key words
HPLC/PTH 1-34/Crude drugs/Related substances/Content分类
医药卫生引用本文复制引用
余邦良,杨柳,王秀玲..HPLC法测定甲状旁腺激素1-34原料药中有关物质的含量[J].中国药房,2011,22(25):2374-2376,3.
