HPLC测定依卡倍特钠颗粒有关物质及其含量

Determination of Contents and Related Substances of Ecabet Sodium Granules by HPLC

摘要: 目的建立HPLC测定依卡倍特钠颗粒的含量及有关物质的方法。方法采用美国热电公司C18色谱柱(250 mm×4.6 mm，5 μm)；流动相为乙腈-1.36%磷酸二氢钾溶液(27︰73)；柱温为室温；检测波长为271 nm。结果依卡倍特钠在0.010 26~0.153 9 mg·mL^-1浓度范围内呈良好的线性关系(r=0.999 8)，平均回收率为99.8%；有关物质的破坏性试验中杂质与主峰分离度符合规定。结论该方法简便、准确、专属性强，可用于控制依卡倍特钠颗粒的质量。

Abstract: OBJECTIVE To establish the HPLC method for determining the contents and related substances in Ecabet sodium granules. METHODS C18 column (250 mm×4.6 mm, 5 μm) was used. The mobile phase consisted of acetonitrile-1.36% potassium dihydrogen phosphate (27︰73), and the detective wavelength was 271 nm. RESULTS The linearity was obtained over the range of 0.010 26-0.153 9 mg·mL^-1, (r=0.999 8). The average recovery was 99.8%. The related substances were well separated in the degradation test. CONCLUSION The method is simple, convenient, accurate and can be employed to assay the contents and related substances in Ecabet sodium granules for its quality control.