摘要
目的采用反相高效液相色谱法测定注射用前列地尔的有关物质和降解产物。方法使用C_8色谱柱(250mm×4.6mm,5μm),以磷酸盐缓冲液(0.015 mol·L^(-1)磷酸二氢钾溶液)-乙腈(62:38,V/V)为流动相进行洗脱;流速1.0mL·min^(-1);检测波长215nm;柱温30℃。结果主峰和各杂质峰均达到基线分离,理论板数按前列腺素E_1峰计算不低于13 000。前列腺素E_1质量浓度的线性范围为1.5～6.0 mg·L^(-1)(r=0.999 7),15-酮基-前列腺素E_1为0.75～3.0 mg·L^(-1)(r=0.999 0),前列腺素A_1为1.0～4.0mg·L^(-1)(r=0.999 7)。结论经方法学验证,该方法灵敏、准确,适用于注射用前列地尔的有关物质的测定。
AIM To establish a RP-HPLC method to detect the related substances of alprostadil for injection. METHODS The C8 column（250 mm×4.6 mm,5μm）was used,and 0.015 mol·L^-1 potassium dihydrogen phosphate solution-acetonitrile（62：38,V/V）was used as the mobile phase.The flowing rate was 1.0 mL·min^-1.The detection wavelength was 215 nm.RESULTS Chief peak and every impurity peak were separated well.The theoretical plate number of prostaglandin E_1 was no less than 13 000.CONCLUSION The method is proved to be sensitive and accurate. It＇ s quite suitable to be used in the analysis of related substances of alprostadil for injection.
出处
《中国临床药学杂志》
CAS
2011年第4期234-236,共3页
Chinese Journal of Clinical Pharmacy
