中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
10期
1629-1631
,共3页
张倩如%张琪%郭小丰%郭文敏
張倩如%張琪%郭小豐%郭文敏
장천여%장기%곽소봉%곽문민
利伐沙班%对映异构体%高效液相色谱法%含量测定
利伐沙班%對映異構體%高效液相色譜法%含量測定
리벌사반%대영이구체%고효액상색보법%함량측정
Rivaroxaban%Enantiomer%HPLC%Determination
目的：：建立高效液相色谱法测定利伐沙班中对映异构体含量。方法：色谱柱为 Chiralpak IA(250 mm ×4.6 mm,5μm),流动相为100%甲醇,流速为1.0 ml·min-1,检测波长为250 nm,柱温为40℃。结果：利伐沙班与其对映异构体之间的分离度大于2.0,两者在0.5~1000.00μg·ml-1范围内呈良好的线性关系,r均为0.9999,对映异构体检测限为0.17 ng,平均加样回收率为102.9%,RSD为1.54%(n=6)。结论：该方法准确、快速,可用于利伐沙班中对映异构体的含量测定。
目的：：建立高效液相色譜法測定利伐沙班中對映異構體含量。方法：色譜柱為 Chiralpak IA(250 mm ×4.6 mm,5μm),流動相為100%甲醇,流速為1.0 ml·min-1,檢測波長為250 nm,柱溫為40℃。結果：利伐沙班與其對映異構體之間的分離度大于2.0,兩者在0.5~1000.00μg·ml-1範圍內呈良好的線性關繫,r均為0.9999,對映異構體檢測限為0.17 ng,平均加樣迴收率為102.9%,RSD為1.54%(n=6)。結論：該方法準確、快速,可用于利伐沙班中對映異構體的含量測定。
목적：：건립고효액상색보법측정리벌사반중대영이구체함량。방법：색보주위 Chiralpak IA(250 mm ×4.6 mm,5μm),류동상위100%갑순,류속위1.0 ml·min-1,검측파장위250 nm,주온위40℃。결과：리벌사반여기대영이구체지간적분리도대우2.0,량자재0.5~1000.00μg·ml-1범위내정량호적선성관계,r균위0.9999,대영이구체검측한위0.17 ng,평균가양회수솔위102.9%,RSD위1.54%(n=6)。결론：해방법준학、쾌속,가용우리벌사반중대영이구체적함량측정。
Objective:To establish a method for the determination of enantiomer in rivaroxaban by HPLC. Methods:A Chiralpak IA column (250 mm × 4. 6 mm, 5 μm) was used with the mobile phase of 100% methanol. The flow rate was 1. 0 ml·min-1 . The detection wavelength was set at 250 nm and the column temperature was 40℃. Results:The resolution of rivaroxaban and the enanti-omer was above 2. 0. The linear range of them was 0. 5-1 000. 00 μg·ml-1(r=0. 999 9). The detection limit of the enantiomer was 0. 17ng and the average recovery was 102. 9% with RSD of 1. 54%(n=6). Conclusion:The method is accurate and rapid, and suit-able for the determination of the enantiomer in rivaroxaban.
