高效液相色谱法分离测定硫酸卷曲霉素的4个组分  

HPLC isolation and determination of the four components of capreomycin sulfate

作　　者：王立萍[1] 刘英[1] 杨淑先[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《药物分析杂志》2012年第7期1285-1288,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立1种分离硫酸卷曲霉素4个组分的高效液相色谱法,并定量分析检测了各组分。方法:采用Venusil ASB C18柱(250 mm×4.6 mm,5μm),柱温25℃,流动相为磷酸盐缓冲液(称取磷酸二氢钾54.4 g,加水至1.5 L,溶解,用磷酸调pH至2.5,加入己烷磺酸钠9.4 g,用水稀释至2.0 L)-甲醇-乙腈(84∶8∶8),检测波长:268 nm,流速:0.9 mL.min-1,进样量:20μL。结果:建立的HPLC法能基线分离硫酸卷曲霉素的4个组分,并能有效分离原料及制剂中的杂质。结论:本方法能更好地控制硫酸卷曲霉素原料和制剂的质量。Objective：To develop an HPLC method and use it to analyze the four components of capreomycin sul- fate quantitatively. Methods：A Venusil ASB ClS column（250 mm ×4. 6 mm,5 μm）was used. The column temper- ature was 25 ℃. The mobile phase was phosphate solution （monopotassium phosphate （54. 4 g） was dissolved in 1.5 L of water. Then, phosphoric acid was added to adjust the pH to 2.5. After that, 9. 4 g of sodium hexanesul- fonate was added. The solution was diluted with water to 2.0 L） - methanol - acetonitrile （84： 8： 8）. The detection wavelength was set at 268 nm. The velocity was 0. 9 mL . min^-1. The sample amount was 20 μL. Results： The baseline separation of the four components of capreomycin sulfate by HPLC was achieved. The impurities in capreo- mycin sulfate （raw materials） and its preparations were isolated. Conclusion： The HPLC method is useful in qual- ity control of capreomycin sulfate （raw materials） and its preparations.

关 键 词：硫酸卷曲霉素 水溶性多肽类抗生素 环状多肽 多组分抗结核药物 组分分析 高效液相色谱法 杂质分离 

分 类 号：R917[医药卫生—药物分析学]