摘要
目的 :为西罗莫司研制过程中提供质量控制。方法 :色谱柱为ZorboxSB C1 8(4 6mm× 2 50mm ,5μm) ;流动相为乙腈—水 (65∶35) ;流速为 1ml/min ;柱温为 62℃ ;紫外检测波长为 2 77nm。结果 :方法具有较高的专属性 ;精密度日内RSD为 0 35 % ,日间RSD为 0 96 % ;线性范围为 0 0 0 0 0 1～ 30 μg(r=0 9999) ;最低检测限 (LOD)与最低检测量 (LOQ)分别为 0 0 2 5ng与 0 0 8ng。结论 :建立了一种专属、灵敏、快速。
Objective:To establish a method for the determination of sirolimus and its related impurities by reverse phase high performance liquid chromatography. Method: Chromatographic conditions were as follows: a Zorbox SB C 18 (4 6mm×250mm, 5μm)column, the mobile phase acetonitrile-water(65∶35), flow rate 1 ml/min, the temperature of column 62℃, the uv detection wavelength 277nm. Results: The linearity range was from 0 00001～30μg ( r =0 9999). The limit of detection (LOD)and limit of quantitation (LOQ) values were 0 025ng and 0 08ng. RSD in the same day and between day was 0 35% and 0 96% respectively. Conclusion: The method was efficient, reproducible and feasible for determining sirolimus and its related impurities.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2002年第9期538-540,共3页
Chinese Journal of Antibiotics
