中国实用医药
中國實用醫藥
중국실용의약
CHINA PRACTICAL MEDICAL
2014年
5期
4-5
,共2页
赵亮%徐炳欣%石晓晓%兰丙欣
趙亮%徐炳訢%石曉曉%蘭丙訢
조량%서병흔%석효효%란병흔
紫杉醇注射液%高效液相色谱法%含量测定%有关物质
紫杉醇註射液%高效液相色譜法%含量測定%有關物質
자삼순주사액%고효액상색보법%함량측정%유관물질
Paclitaxel injection%HPLC%Determination%Related substances
目的：建立高效液相色谱法测定紫杉醇注射液的含量及有关物质的方法。方法应用HPLC法,色谱柱为Hypersil BDS C18(4.6 mm×250 mm,5μm),检测波长为227 nm,柱温35℃,流速为1.0 ml/min,进样量为20μl,流动相为甲醇-乙腈-水(45：30：25, v/v)。结果紫杉醇浓度在10~125 mg·L-1的范围内,溶液的浓度与色谱峰面积线性关系良好(R2=0.9998, n=6)。精密度试验RSD为0.17%(n=5),平均加样回收率为99.33%, RSD=0.38%。结论本方法简便、准确、快速、重复性好,可用于紫杉醇注射液的含量测定和有关物质检查。
目的：建立高效液相色譜法測定紫杉醇註射液的含量及有關物質的方法。方法應用HPLC法,色譜柱為Hypersil BDS C18(4.6 mm×250 mm,5μm),檢測波長為227 nm,柱溫35℃,流速為1.0 ml/min,進樣量為20μl,流動相為甲醇-乙腈-水(45：30：25, v/v)。結果紫杉醇濃度在10~125 mg·L-1的範圍內,溶液的濃度與色譜峰麵積線性關繫良好(R2=0.9998, n=6)。精密度試驗RSD為0.17%(n=5),平均加樣迴收率為99.33%, RSD=0.38%。結論本方法簡便、準確、快速、重複性好,可用于紫杉醇註射液的含量測定和有關物質檢查。
목적：건립고효액상색보법측정자삼순주사액적함량급유관물질적방법。방법응용HPLC법,색보주위Hypersil BDS C18(4.6 mm×250 mm,5μm),검측파장위227 nm,주온35℃,류속위1.0 ml/min,진양량위20μl,류동상위갑순-을정-수(45：30：25, v/v)。결과자삼순농도재10~125 mg·L-1적범위내,용액적농도여색보봉면적선성관계량호(R2=0.9998, n=6)。정밀도시험RSD위0.17%(n=5),평균가양회수솔위99.33%, RSD=0.38%。결론본방법간편、준학、쾌속、중복성호,가용우자삼순주사액적함량측정화유관물질검사。
Objective To establish a method for the determination of paclitaxel injection and its related substances by High Performance Liquid Chromatography(HPLC). Methods The determination was performed on the following conditions:the colum was Hypersil BDS C18(4.6 mm×250 mm, 5μm), the mobile phase was methanol-acetonitrile-water (45:30:25, v/v), the detected wavelength was 227 nm, the colum temperature was 35℃, the flow rate was 1.0 ml/min, the injection volume was 20μl. Results The linear concentration range was from 10 to 125 mg·L-1 of paclitaxel(R2=0.9998, n=6). The RSD of precision test was 0.17%. The average recovery was99.33%, RSD=0.38%. Conclusion The method is simple, accurate, rapid and reproducible. It can be used to detect the content of paclitaxel injection and its related substances.
