目的: 通过对中国药典2010年版、英国药典2011年版及文献报道的辛伐他汀片有关物质分析方法的比较,探讨并完善了辛伐他汀片的有关物质控制方法。 方法: 采用SUPELCO C18色谱柱(4.6 mm×33 mm,3 μm);Alltima C18色谱柱(4.6 mm×100 mm,3 μm);Thermo hypersil gold C18色谱柱(4.6 mm×250 mm,5 μm),通过破坏降解试验,制备含有辛伐他汀羟基酸和脱水辛伐他汀的专属性考察溶液,以辛伐他汀及其杂质的分离分析情况为指标,选用ChP 2010、BP 2011和文献方法,分析比较了3种方法的专属性、灵敏度和准确度。 结果: 3种方法专属性均较好,而ChP 2010的方法灵敏度最高,分析时间最短,检出杂质最多,增加含有洛伐他汀、降解物辛伐他汀羟基酸和脱水辛伐他汀的系统适用性试验,更提高了分析方法的专属性和准确性。 结论: ChP 2010的方法最优,专属性较强,灵敏度较高,更适合于辛伐他汀片有关物质的检测。
Objective: To compare and optimize 3 testing methods for analysis of the related substances in simvastatin tablets,and determine which available method was most appropriate for quality control. Methods: On the basis of the 3 methods and 3 chromatographic columns,the special solution contains simvastatin hydroxyacid and anhydro simvastatin were analyzed respectively.Specificity,sensitivity and accuracy were compared among different methods. Results: Specificity of the three methods were all good;the method of ChP 2010 showed the highest sensitivity,the shortest analysis time,and the most impurities were detected with this method;,moreover,system applicability test containing lovastatin,degradants simvastatin hydroxyacid and anhydro simvastatin were added in the method,which improved the specificity and accuracy of the analysis method. Conclusion: The ChP 2010 method is optimal,specific,and sensitive,which can be used for the determination of related substances in simvastatin tablets.
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