中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
5期
711-713
,共3页
高效液相色谱法%注射用福沙匹坦二甲葡胺%乙二胺四乙酸钙钠
高效液相色譜法%註射用福沙匹坦二甲葡胺%乙二胺四乙痠鈣鈉
고효액상색보법%주사용복사필탄이갑포알%을이알사을산개납
HPLC%Fosaprepitant dimeglumine for injection%Calcium disodium edetate
目的：：建立高效液相色谱法测定注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠的含量。方法：采用Agilent Zorbax Eclipse XDB C18(250 mm×4.6 mm,5μm)色谱柱；以0.2%四丁基氢氧化铵溶液(用磷酸调节pH4.0)-乙腈(85∶15)为流动相,流速为1.0 ml·min-1,检测波长为254 nm,柱温为35℃,进样量为20μl。结果：乙二胺四乙酸钙钠在26.06~104.24μg· ml-1(r=0.9998)范围内呈现良好的线性关系；平均回收率为99.51%(RSD=0.25%,n=9)。结论：该方法简便、灵敏、准确、专属性强,重复性好,可作为注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠含量测定的方法。
目的：：建立高效液相色譜法測定註射用福沙匹坦二甲葡胺中乙二胺四乙痠鈣鈉的含量。方法：採用Agilent Zorbax Eclipse XDB C18(250 mm×4.6 mm,5μm)色譜柱；以0.2%四丁基氫氧化銨溶液(用燐痠調節pH4.0)-乙腈(85∶15)為流動相,流速為1.0 ml·min-1,檢測波長為254 nm,柱溫為35℃,進樣量為20μl。結果：乙二胺四乙痠鈣鈉在26.06~104.24μg· ml-1(r=0.9998)範圍內呈現良好的線性關繫；平均迴收率為99.51%(RSD=0.25%,n=9)。結論：該方法簡便、靈敏、準確、專屬性彊,重複性好,可作為註射用福沙匹坦二甲葡胺中乙二胺四乙痠鈣鈉含量測定的方法。
목적：：건립고효액상색보법측정주사용복사필탄이갑포알중을이알사을산개납적함량。방법：채용Agilent Zorbax Eclipse XDB C18(250 mm×4.6 mm,5μm)색보주；이0.2%사정기경양화안용액(용린산조절pH4.0)-을정(85∶15)위류동상,류속위1.0 ml·min-1,검측파장위254 nm,주온위35℃,진양량위20μl。결과：을이알사을산개납재26.06~104.24μg· ml-1(r=0.9998)범위내정현량호적선성관계；평균회수솔위99.51%(RSD=0.25%,n=9)。결론：해방법간편、령민、준학、전속성강,중복성호,가작위주사용복사필탄이갑포알중을이알사을산개납함량측정적방법。
Objective:To establish an HPLC method for the determination of calcium disodium edetate in fosaprepitant dimeglu-mine for injection. Methods:The chromatographic column was Agilent Zorbax Eclipse XDB C18(250 mm ×4.6 mm,5μm). The mo-bile phase consisted of 0. 2% tetrabutylammonium hydroxide(adjusting pH to 4. 0 with phosphoric acid)-acetonitrile(85∶15). The flow rate was 1. 0 ml·min-1 . The detection wavelength was 254 nm. The chromatographic column temperature was 35℃. The injection volume was 20μl. Results:The calibration curve was linear within the range of 26. 06-104. 24μg·ml-1(r=0. 999 8) for calcium di-sodium edetate. The average recovery was 99. 51% (RSD=0. 25%, n=9). Conclusion: The method is simple, rapid, accurate, specific and reproducible, and can be used in the determination of calcium disodium edetate in fosaprepitant dimeglumine for injection.
