首页|高效液相色谱法测定呋喃烯啶原料药含量

高效液相色谱法测定呋喃烯啶原料药含量

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目的 测定呋喃烯啶原料药含量,以对其质量进行控制。方法 采用高效液相色谱法,色谱柱为 WondaCract ODS-2(4。6 mm×250 mm,5 μm),流动相为水(磷酸调节水相pH 4。0)-乙腈(60∶40),流速为1。0 ml·min-1,柱温为30℃,检测波长为292 nm,进样量为20 μl,运行时间为30 min,平衡时间为20 min。结果 呋喃烯啶线性范围为0。1~0。8 mg·ml-1(r=0。999 7);在专属性考察中,呋喃烯啶与其降解物质分离良好;仪器精密度试验RSD为0。46%(n=6),重复性试验RSD为0。41%(n=6);平均回收率为100。6%,RSD为0。97%(n=9)。结论 该方法操作简便、灵敏度高、分离度好、结果准确,可作为呋喃烯啶原料药质量控制的方法。
Content determination of Raw Materials of Furagin by High Performance Liquid Chromatography
Objective To determine the contents of active pharmaceutical ingredients in raw materi-als of furagin by high performance liquid chromatography in order to contribute to quality control.Methods The column was a WondaCract ODS-2(4.6 mm×250 mm,5 μm),the mobile phase was water(pH 4.0,the aqueous phase adjusted by phosphoric acid)-acetonitrile(60∶40),the flow rate was 1.0 ml·min-1,the column temperature 30℃,the detection wavelength 292 nm,the injection volume 20 μl,the running time 30 min,and the duration of equilibration was 20 min.Results The linear range of furagin was 0.1-0.8 mg·ml-1(r=0.9997).Furagin was well separated from its degraded substances in the specificity test.The RSD was 0.46%(n=6)for the instrumental precision test and 0.41%(n=6)for the reproducibility test.The mean recovery was 100.6%with an RSD of 0.97%(n=9).Conclusion This method is simple,sensitive,with good separation and accurate results,which can be used as a method for quality control of active pharmaceutical ingredients in raw materials of furagin.

furaginraw materialsHPLCquality control

宋子君、潘雪飞、徐欣昌

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310009 浙江杭州,杭州市第三人民医院

311121 浙江杭州,杭州师范大学药学院

呋喃烯啶 原料药 高效液相色谱法 质量控制

2024

解放军药学学报
中国人民解放军总后勤部卫生部 药品仪器检验所

解放军药学学报

影响因子:0.529
ISSN:1008-9926
年,卷(期):2024.37(6)