摘要
目的建立依托泊苷软胶囊的有关物质及含量的HPLC测定方法。方法色谱柱为Inertsil(Dia-monsil)250×4.6mm(5μm);以乙腈—醋酸盐缓冲液(pH4.0)(取醋酸钠5.44g,加水溶解并稀释至2000ml,用冰醋酸调节pH值至4.0)(20∶80)为流动相A;以乙腈—醋酸盐缓冲液(pH4.0)(60∶40)为流动相B;梯度洗脱,流速为1.5ml/min。柱温为40℃;检测波长为254nm。结果依托泊苷与各杂质峰、空白辅料峰达到基线分离。在0.576～240μg/ml范围内线性关系良好。依托泊苷的检测限为2.19ng,平均回收率为100.0%,RSD为0.7%(n=9)。结论本法简便,专属性、重现性好,结果准确可靠,可用于依托泊苷软胶囊的含量测定及有关物质检测。
Objective To establish an high performance liquid chromatography (HPLC) method for determination of content and related substances of etoposide soft capsules.Methods The column was Inertsil (Diamonsil)250×4.6mm(5μm).Mobile phase A:acetonitrile: sodium acetate buffer (Take the sodium acetate 5.44g,dissolved in water and diluted to 2000ml;adjusted with glacial acetic acid to pH of 4.0) (20∶ 80).Mobile phase B: acetonitrile: sodium acetate buffer (60∶ 40).The gradient flow rate was 1.5ml/min.The column temperature was 40℃ and detection wavelength was 254nm.Results Good resolution of etoposide,related substance and adjuvant.Etoposide and the peaks of impurities,excipients peaks reached the baseline separation.The linear ranges of etoposide was 0.576~240μg/ml.The LOD of etoposide was 2.19ng and average recovery was 100.0%( RSD 0.7%)(n=9).Conclusion The method is simple,reproducible,accurate and suitable for determination of the content and related substances of Etoposide soft capsules.
出处
《临床合理用药杂志》
2013年第11期33-35,共3页
Chinese Journal of Clinical Rational Drug Use
