食品与药品
食品與藥品
식품여약품
FOOD AND DRUG
2015年
3期
195-197
,共3页
贾玲晓%唐磊%张淑婷%宋瑞芝%高占文
賈玲曉%唐磊%張淑婷%宋瑞芝%高佔文
가령효%당뢰%장숙정%송서지%고점문
甲磺酸达比加群酯%含量测定%高效液相色谱法
甲磺痠達比加群酯%含量測定%高效液相色譜法
갑광산체비가군지%함량측정%고효액상색보법
dabigatran etexilate mesylate%determination%HPLC
目的：建立高效液相色谱（HPLC）测定甲磺酸达比加群酯含量的方法。方法采用十八烷基键合硅胶色谱柱（4.6 mm×250 mm，5μm），以0.01 mol/L甲酸铵-乙腈为流动相，梯度洗脱，流速1.0 mL/min；检测波长315 nm。结果线性范围为0.098~1.17 mg/mL，r=0.9999；平均回收率98.96%，RSD 1.4%（n=9）。结论本方法简单、迅速、可靠，可用于甲磺酸达比加群酯的检测和质量控制。
目的：建立高效液相色譜（HPLC）測定甲磺痠達比加群酯含量的方法。方法採用十八烷基鍵閤硅膠色譜柱（4.6 mm×250 mm，5μm），以0.01 mol/L甲痠銨-乙腈為流動相，梯度洗脫，流速1.0 mL/min；檢測波長315 nm。結果線性範圍為0.098~1.17 mg/mL，r=0.9999；平均迴收率98.96%，RSD 1.4%（n=9）。結論本方法簡單、迅速、可靠，可用于甲磺痠達比加群酯的檢測和質量控製。
목적：건립고효액상색보（HPLC）측정갑광산체비가군지함량적방법。방법채용십팔완기건합규효색보주（4.6 mm×250 mm，5μm），이0.01 mol/L갑산안-을정위류동상，제도세탈，류속1.0 mL/min；검측파장315 nm。결과선성범위위0.098~1.17 mg/mL，r=0.9999；평균회수솔98.96%，RSD 1.4%（n=9）。결론본방법간단、신속、가고，가용우갑광산체비가군지적검측화질량공제。
Objective To establish an HPLC method for determination of dabigatran etexilate mesylate.Methods The C18 column (4.6 mm×250 mm, 5μm) was used.The gradient elution was adopted, with the mobile phase composed of 0.01 mol/L ammonium formate and acetonitrile. The flow rate was 1.0 mL/min and the detective wavelength was 315 nm.Results The linear range of dabigatran etexilate mesylate was 0.098-1.17 mg/mL and the regression coefficient was 0.9999. The average recovery was 98.96 %, withRSD of 1.4 % (n=9).Conclusion The method was simple, quick and reliable. It can be used for actual test and quality control of dabigatran etexilate mesylate.
