低取代羟丙纤维素羟丙氧基含量气相色谱测定方法的研究

摘要

Objective:To revise the assay method hydroxypropoxy group of hydroxypropyl cellulose in Chinese Pharmacopoeia 2005 E-dition.Methods:GC was performed and the researches were verified.Results: The average recovery rate was 98.09%.The RSD in same laboratory of three determinations was 0.60%,the average RSD of three batch of samples by three different laboratories was 7.2%and the RSD of seven determinations of the same sample solution in 5 days was 1.23%.Conclusion:The method is proved to be accu-rate and convenient.%目的：修订2005年版《中国药典》中辅料羟丙纤维素羟丙氧基含量测定方法。方法：采用气相色谱方法对低取代羟丙纤维素羟丙氧基含量进行测定，并进行了方法学验证。结果：平均回收率为98.09％，同一实验室三次测定结果的RSD为0.60％，三批样品在三个不同实验室测定结果的平均RSD为7.2％，供试品溶液在5 d内七次测定结果的RSD为1.23％。结论：方法准确、简便，为《中国药典》2010年版药用辅料低取代羟丙纤维素羟丙氧基含量测定方法的修订提供了依据。