劳拉西泮片有关物质检查方法的比较

摘要

Objective To compare and discuss the differences and similarities of related substances test method on lorazepam tablets between Chinese pharmacopoeia 2015 edition two and United States pharmacopoeia 39 edition. MethodsThe differences in the aspects of impurity separation capability, methodology and the consistency of test results etc between the two test methods were compared and evaluated.ResultsThe separation effect of major impurities in lorazepam tablets by the test method of Chinese pharmacopoeia was bad, which could influence the determination of related substances result, while the impurity separation effect by the test method of United States pharmacopoeia was good, had high sensitivity and improved the specificity of analytical method and the accuracy of results.Conclusion The relative substances' test method of United States pharmacopoeia was more suitable for the impurity control in lorazepam tablets, which ensured the quality and safety of the product.%目的：比较并讨论中国药典2015年版二部和美国药典39版中劳拉西泮片有关物质检查方法的异同，为选择合理有效的有关物质检测方法提供科学依据。方法比较两种检测方法在杂质分离能力、方法学以及检测结果一致性等方面的差异并进行评价。结果采用中国药典检测方法对劳拉西泮片中主要杂质之间的分离效果差，从而影响有关物质结果的判定；美国药典检测方法杂质分离好，灵敏度高，提高了分析方法的专属性和结果的准确性。结论美国药典有关物质检测方法更适合劳拉西泮片中杂质的控制，从而保证该产品的质量和安全。