论文部分内容阅读
目的 :建立注射用依米配能 /西司它丁钠复方制剂的高效液相色谱含量测定方法。方法 :胶束液相色谱法。色谱条件如下 :分析柱为SpherisorbC8柱 ;柱温 30℃ ;流动相为含 0 .0 2moL/L十二烷基硫酸钠的pH6.9的磷酸盐缓中液 ;检测波长 2 54nm ;流速 0 .8mL/min。结果 :依米配能和西司它丁钠均在 1 0 0～ 1 0 0 0 μg/mL范围内线性良好 ,r分别为 0 .9998和 0 .9999,平均回收率分别为依米配能 98.96% (RSD =1 .1 2 % ) ,西司它丁钠 99.84 % (RSD =0 .4 5% )。结论 :方法简便、快速、准确、消耗低 ,适用于依米配能 /西司它丁钠的复方制剂的质量分析。
OBJECTIVE: To establish a method for the determination of high performance liquid chromatography (HPLC) of the compound preparation of mizanpina / cilastatin sodium for injection. Methods: Micellar liquid chromatography. Chromatographic conditions are as follows: the analytical column SpherisorbC8 column; column temperature 30 ℃; mobile phase containing 0. 02moL / L sodium dodecyl sulfate pH6.9 phosphate buffer solution; detection wavelength of 254nm; 8 mL / min. Results: Ezetimine and cilastatin sodium showed good linearities in the range of 100 ~ 100 μg / mL, with r of 0.9998 and 0.9999, respectively. The average recoveries were linear 98.96% (RSD = 1.12%) and ciclodextrin 99.84% (RSD = 0.54%). Conclusion: The method is simple, rapid, accurate and low in consumption. It is suitable for the quality analysis of compound preparations of mizorone / cilastatin sodium.