毛细管胶束电动色谱-紫外间接检测环胞素制剂中的有机溶剂

用毛细管胶束电动色谱-紫外间接检测环胞素软胶囊及环胞素注射液中的有机溶剂含量.采用非涂层弹性石英毛细管;操作缓冲液为含0.26mol/L十二烷基硫酸钠的0.02mol/L苯巴比妥钠溶液(pH9.0);检测波长为235nm(间接检测);电泳过程中在进样端始终外加适当的压力使基线保持稳定.以甲醇为内标物,乙醇和1,2-丙二醇均在2.6～18mg/ml范围内呈良好的线性关系.连续进样分析所得峰面积和迁移时间的相对标准偏差均不大于1.3%.环胞素软胶囊中乙醇和1,2-丙二醇含量测定方法的回收率分别为99,2%和100.7%;环胞素注射液中乙醇含量测定方法的回收率为99.5%.

Determination of organic solvents in cyclosporin preparations by micellar electrokinetic capillary chromatography with indirect UV detection

Organic solvents in cyclosporin soft capsules and cyclosporin injection were determined by micellar electrokinetic capillary chromatography with indirect UV detection.Using an uncoated fused-silica capillary with a 0.02mol/L sodium phenobarbital solution(pH9.0)containing 0.26mol/L sodium dodecyl sulfate as the operating buffer.Indirect UV detection was performed at a wavelength of 235nm.The application of a small amount of inlet pressure during the separation assisted the attainment of a stable baseline.Using methanol as internal standard,the standard curve for ethanol and 1,2-propanediol was rectilinear within the range of 2.6～18mg/ml.The relative standard deviations for peak area and migration time were not more than 1.3%.The recoveries for determination of ethanol and 1,2-propanediol in cyclosporin soft capsules were 99.2%and 100.7%respectively.The recovery for determination of ethanol in cyclosporin injections was 99.5%.