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作 者:封传华[1] 张静[1] 任琦 徐兰[1] 张浪[1] 陶晓璇[1] 李刚[1] Chuanhua FENG;Jin ZHANG;Qi REN;Lan XU;Lang ZHANG;Xiaoxuan TAO;Gang LI(Department of Pharmacy,No.94 Hospital,Nanchang 330002,China;JiangXi Institute for Drug Control,Jiangxi Province,Nanchang 330029,China)
机构地区:[1]解放军第94医院药剂科,南昌330002 [2]江西省药品检验检测研究院,南昌330029
出 处:《医药导报》2018年第12期1485-1487,共3页Herald of Medicine
基 金:军队医疗机构制剂标准单品种研究(14TG0671)
摘 要:目的建立高效液相色谱法同时测定胃特安片中盐酸小檗碱和橙皮苷的含量。方法采用ODS2 C18(4.6 mm×150 mm,5μm)色谱柱,以乙腈-0.1%磷酸溶液(19∶81)为流动相,流速为1 mL·min^(-1),检测波长为265 nm,柱温为30℃,进样量为10μL。结果盐酸小檗碱在5~250μg·mL^(-1)的范围内线性关系良好(r=0.999 5);样品的平均加样回收率为97.4%,RSD为1.9%。橙皮苷在14~700μg·mL^(-1)的范围内线性关系良好(r=0.999 2);样品的平均加样回收率为97.1%,RSD为1.9%。结论建立的方法可快速测定胃特安片中盐酸小檗碱和橙皮苷的含量,且该方法具有操作简便、结果准确、灵敏度高等优点,能够用于控制胃特安片质量。Objective To establish a method for determination of the content of berberine hydrochloride and hesperidin in Weite'an tablet by high performance liquid chromatography. Methods ODS2 C18 (4.6 mm×150 mm, 5 μm) was used as chromatographic column, Acetonitrile-0.1% phosphoric acid solution (19:81) as mobile phase, the flow rate was 1 mL·min-1, the detection wavelength was 265 nm, the column temperature was 30 ℃, and the injection volume was 10 μL. Results Berberine hydrochloride had good linear relationship in the concentration range of 5-250 μg·mL-1(r=0.999 5).The average recovery was 97.4%, RSD was 1.9%.Hesperidin linear relationship in the concentration range of 14-700 μg·mL-1 was good (r=0.999 2); the average recovery was 97.1%, and RSD was 1.9%. Conclusion The established method can quickly determine the content of berberine hydrochloride and hesperidin in Weite'an tablet, has the advantages of simple operation, accurate result,high sensitivity, and can be used for the quality control of Weite'an tablet.
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