摘要
目的:为了更有效地控制成方制剂的安全性,建立高效液相测定方法,对清喉咽合剂中苯甲酸、山梨酸、对羟基苯甲酸酯类等6种防腐剂非法添加进行测定。方法:采用高效液相色谱法,二极管阵列检测器,色谱柱为Thermo BDS HYPERSIL C 18(4.6 mm×250 mm,5μm),流动相为乙腈和0.02 mol·L^-1磷酸二氢铵(用三乙胺调pH值为5.5)梯度洗脱。结果:6种成分线性关系良好,均在线性范围内。61批清喉咽合剂样品中,54批样品按标准检出苯甲酸,且含量在可控范围内,7批样品检出山梨酸,未按标准添加防腐剂。结论:该方法专属性强,简单可行,适用于清喉咽合剂中防腐剂非法添加的检查。
Objective:In order to control the safety of the preparation more effectively,a HPLC method was established to determine the illegal addition of 6 preservatives,such as benzoic acid,sorbic acid,p-hydroxybenzoic acid ester,etc.Methods:High performance liquid chromatography and diode array detector were used.The column was thermo BDS hypersil C 18(4.6 mm×250 mm,5μm).The mobile phase was acetonitrile and 0.02 mol·L^-1 ammonium dihydrogen phosphate(adjusted pH by triethylamine to 5.5).Results:The linear relationship of six components is good,all of them are in the linear range.Among 61 batches of qinghouyan mixture samples,54 batches of samples detected benzoic acid according to the standard,and the content is within the controllable range,7 batches of samples detected sorbic acid,and preservatives were not added according to the standard.Conclusion:This method is specific,simple and feasible,and is suitable for the illegal addition of preservatives in qinghouyan mixture.
作者
周凌
赵月然
康凯
高珊
卢丹
ZHOU Ling;ZHAO Yue-ran;KANG Kai;GAO Shan;LU Dan(Dalian Inspection and Testing Certification Technical Service Center,Liaoning Dalian 116021,China)
出处
《中国药物评价》
2020年第5期370-373,共4页
Chinese Journal of Drug Evaluation
关键词
高相液相色谱法
苯甲酸
山梨酸
清喉咽合剂
High performance liquid chromatographic
Benzoic acid
Sorbic acid
Oral solution of Qinghouyan
