摘要
目的将EP7.0药典中扑米酮相关杂质的检测方法与USP34药典中方法进行比较探讨,比较两种方法。方法流动相A:1.36 g.L-1磷酸二氢钾,流动相B:甲醇,采用梯度洗脱,色谱柱:十八烷基硅胶(4.6 mm×150 mm)(EP7.0),十八烷基硅胶(4.6 mm×100 mm)(USP34),流速3.2 mL.min-1,检测波长:215 nm,进样量:10μL。结果EP7.0方法对扑米酮和杂质B(苯巴比妥)的检测限和定量限都比USP34方法要小,方法较灵敏,且分离效果也较好。结论 EP7.0方法分离效果稍好,能有效灵敏控制测试扑米酮产品中的相关杂质。
Objective To compare the determination methods of primidone related substances in Pharmacopoeia versions EP7.0 and USP34. Methods The gradient elution was carried out with mobile phase A of 1.36 g · L^- 1 potassium dihydrogen phosphate and mobile phase B of methanol. C18 (4.6 mm × 150 mm) column was used in EP7.0 and C18 (4.6 mm × 100 mm I was used in USP34. The flow rate was 3.2 mL · min^-1, the detection wavelength was 215 nm and the injection volume was 10 p.L. Results The quantftation limit and detection limit of primidone and impurity B (phenobarbital) with EP7.0 method were smaller than the results with the USP34 method. The EP7.0 method was more sensitive, of which the separation efficiency was better. Conclusion The separation efficiency of EP7.0 method was better than the USP34 method,and it was more sensitive and effective to determine primidone related substances .
出处
《齐鲁药事》
2012年第11期640-641,共2页
qilu pharmaceutical affairs