维胺酯胶囊有关物质和含量的研究及测定

Study and Determination of Related Substances and Contents in Viaminate Capsules

目的改进和完善维胺酯胶囊含量和有关物质的测定方法,并与法定紫外吸收系数法(UV)进行比较,考察不同方法对含量测定的影响。方法建立高效液相法(HPLC)同时测定含量和有关物质,采用C18色谱柱,以甲醇-水(90∶10)为流动相,流速为1.0 mL·min^-1,检测波长为370 nm。结果该方法的线性范围为4.57~22.85μg·mL^-1(r=1.0),平均回收率(n=9)为99.3%,RSD为0.8%。17批维胺酯胶囊含量测定结果均低于紫外法,杂质检出量为0.29%~2.85%。结论建立的方法专属性强,准确度高,可用于维胺酯胶囊的质量控制。

Objective To improve the method for the determination of related substances and contents in viaminate capsules and compare it with ultraviolet(UV)absorption coefficient method.Methods The related substances and contents were determined by high performance liquid chromatography(HPLC)method with C18 column.The mobile phase consisted of methanol-water(90∶10),the flow rate was 1.0 mL·min^-1 and the detection wavelength was 370 nm.Results The calibration curve showed a good linearity with the range of 4.57 to 22.85μg·mL^-1,and the average recovery was 99.3%,RSD was 0.8%(n=9).The determination results of 17 batches of viaminate capsules by HPLC were lower than those by UV method and the detection of impurities ranged from 0.29%to 2.85%.Conclusion The method we built is specific,accurate and applicable for the quality control of viaminate capsules.