天然产物研究与开发
天然產物研究與開髮
천연산물연구여개발
NATURAL PRODUCT RESEARCH AND DEVELOPMENT
2010年
1期
104-106
,共3页
袁崇均%王笳%陈帅%罗森%周天玉%徐学民
袁崇均%王笳%陳帥%囉森%週天玉%徐學民
원숭균%왕가%진수%라삼%주천옥%서학민
鸢尾苷元磺酸钠%泰克吉宁注射液%含量测定%有关物质%高效液相色谱法
鳶尾苷元磺痠鈉%泰剋吉寧註射液%含量測定%有關物質%高效液相色譜法
연미감원광산납%태극길저주사액%함량측정%유관물질%고효액상색보법
HPLC%tectorigenin sodium sulfonite%Taike Jining Injection%determination%related substance%HPLC
建立高效液相色谱法测定鸢尾苷元磺酸钠(4',5,7-三羟基-6-甲氧基异黄酮-5'-磺酸钠)及其制剂泰克吉宁注射液的含量及有关物质.采用C_(18)色谱柱(150×4.6 mm,5μm),流动相为甲醇-5%醋酸水(80:20),流速为1.0 mL/min,检测波长为263 nm.鸢尾苷元磺酸钠在11~100 μg/mL范围内线性关系良好,回归方程Y=43.3609X-1.5973(r=0.99998),平均回收率为99.77%(n=9).最低检测限为0.052 μg/mL,与有关物质分离良好.本法快速、简便、准确,专属性强.
建立高效液相色譜法測定鳶尾苷元磺痠鈉(4',5,7-三羥基-6-甲氧基異黃酮-5'-磺痠鈉)及其製劑泰剋吉寧註射液的含量及有關物質.採用C_(18)色譜柱(150×4.6 mm,5μm),流動相為甲醇-5%醋痠水(80:20),流速為1.0 mL/min,檢測波長為263 nm.鳶尾苷元磺痠鈉在11~100 μg/mL範圍內線性關繫良好,迴歸方程Y=43.3609X-1.5973(r=0.99998),平均迴收率為99.77%(n=9).最低檢測限為0.052 μg/mL,與有關物質分離良好.本法快速、簡便、準確,專屬性彊.
건립고효액상색보법측정연미감원광산납(4',5,7-삼간기-6-갑양기이황동-5'-광산납)급기제제태극길저주사액적함량급유관물질.채용C_(18)색보주(150×4.6 mm,5μm),류동상위갑순-5%작산수(80:20),류속위1.0 mL/min,검측파장위263 nm.연미감원광산납재11~100 μg/mL범위내선성관계량호,회귀방정Y=43.3609X-1.5973(r=0.99998),평균회수솔위99.77%(n=9).최저검측한위0.052 μg/mL,여유관물질분리량호.본법쾌속、간편、준학,전속성강.
To establish an HPLC method to determine the content and the related substances of teetorigenin sodium sulfo-nite (4' ,5,7-trihydroxy-6-methoxy-7-hydroxymethylisotlavone-5'-sulphoric acid sodium) and its preparation-Taikejining Injection.The HPLC system consisted of C18 column(150 × 4.6 mm,5 μm) ,methanol-5% acetic acid solution(80:20) as mobile phase with UV detection at 263 nm,flow rate: 1.0 mL/min, The linear range was 11-100 μg/mL, r =0.99998 ,the average recovery was 99.77% (n =9).The detection limit was 0.052 μg/mL.The related substances were separated well from tectorigenin sodium sulfonite.This method is rapid, simple, specific and accurate.