摘要
目的测定维胺酯胶囊中维胺酯的含量及有关物质。方法采用日本分光JASCO-1500系列高效液相色谱仪,KromasilC18柱(250 mm×4.6 mm,5μm),以甲醇-醋酸(100∶0.2)为流动相,流速为0.75 ml.min-1,紫外检测波长370 nm,灵敏度AuFs=0.02,柱温为25℃。结果维胺酯在2.0~12.0 mg.L-1范围内线性关系良好(r=0.999 9),平均回收率99.9%(n=3),方法精密度RSD=0.64%;有关物质各杂质峰与主峰之间的分离良好。结论该法操作简便,专属性强,结果准确可靠,可有效控制药品质量。
Objective To determine the content of Viaminate and related substances in Viaminate capsules.Methods HPLC method was applied and Kromasil C18column(250 mm×4.6 mm,5 μm)was used in JASCO-1500 with mobile phase of methamol-acetic acid(100∶ 0.2).The flow rate was 0.75 ml·min-1 and the detection wavelength was set at 370nm.Sensitivity AuFs was 0.02.The column temperature was set at 25℃.Results The linear relations were at its best(r =0.999 9) with the concentration range of Viaminate in 2.0~12.0 mg·L-1.The average recovery was 99.9%(n=3),and RSD was 0.64%.Conclusion The method is rapid,simple,exclusive and accurate,which can be used for quality control of drug effectively.
出处
《安徽医药》
CAS
2012年第1期42-44,共3页
Anhui Medical and Pharmaceutical Journal
关键词
HPLC
维胺酯胶囊
维胺酯
有关物质
high performance liquid chromatograph
viaminate capsules
viaminate
retinamido-ester