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目的 :探讨用自制硅胶G板检查辛伐他汀原料中总杂质的方法。方法 :样品用 0 0 5% (W/V) 2 ,6-二叔丁基甲酚 (BHT)的乙腈溶液配制成浓度为 1 0 0mg·ml- 1的溶液 ,再分别稀释为 0 4 ,0 2 ,0 1 ,0 0 5mg·ml- 1,取样1 0 μl,点于自制薄层板上 ,用含 0 0 5% (W/V)BHT的环已烷—氯仿—异丙醇 ( 5∶2∶1 )展开剂展开 ,喷显色剂视检。结果 :三批样品用本法检测有 2 -3个杂质斑点 ,最大杂质量 <0 4 % ,总杂质量 <1 %。结论 :该方法适用于本品杂质检查
Objective: To explore the method of using homemade silica gel G plate to check the total impurities in simvastatin. Methods: Samples were prepared into 100 mg · ml-1 solution with 0 5% (w / v) 2,6-di-tert-butylcresol (BHT) in acetonitrile and then diluted to 0 4, 0 2 , 0 1, 0 5 mg · ml-1, 10 μl of sample was taken and placed on a self-made thin plate. The membrane was eluted with cyclohexane-chloroform- 2: 1) Expansion agent deployment, spray color visual inspection. Results: Three batches of samples were detected by this method, with 2-3 impurity spots, with the largest impurity amount <0 4% and the total impurity amount <1%. Conclusion: This method is suitable for the impurity inspection