两种小儿抗感冒颗粒剂中胆红素含量测定方法的研究  

Study on Determination Method for Bilirubin in Two Kinds of Pediatric Anti-cold Granules

作　　者：孙迎春 程卉[2] 刘东风 SUN Ying-chun;CHENG Hui;LIU Dong-feng(Anqing Food and Drug Inspection Center,Anqing 246000,China;Anhui University of Chinese Medicine,Hefei 230038,China)

机构地区：[1]安庆市食品药品检验中心,安徽安庆246000 [2]安徽中医药大学,安徽合肥230038

出　　处：《海峡药学》2022年第6期48-51,共4页Strait Pharmaceutical Journal

摘　　要：目的优化试验条件,探索与仪器兼容性更好的流动相,建立高效液相色谱(HPLC)法测定两种小儿抗感冒制剂〔小儿氨酚黄那敏颗粒、小儿氨酚烷胺颗粒〕中胆红素的含量。方法采用菲罗门Titank C_(18)(150 mm×4.6 mm,5μm)色谱柱,以甲醇-乙腈-1%冰醋酸(88∶10∶2)为流动相,检测波长为449 nm,柱温为30℃,流速为1.0 mL·min^(-1),进样量为10μL。结果胆红素进样量在1.221~12.21μg·mL^(-1)范围内与峰面积呈良好线性关系(R^(2)=0.9995,n=5);小儿氨酚黄那敏颗粒和小儿氨酚烷胺颗粒平均加样回收率分别为98.0%、98.6%,RSD分别为1.1%、1.4%。结论与传统方法相比,该方法流动相毒性较小,简单易得,试验结果准确可靠,可用于小儿氨酚黄那敏颗粒、小儿氨酚烷胺颗粒中胆红素的含量测定。OBJECTIVE To optimize the test conditions and explore a more compatible mobile phase with the instrument,an HPLC method was established for the determination of bilirubin in two kinds of pediatric anti-cold granules〔pediatric paracetamol,artificial cow-bezoar and chlorphenamine maleate granules;pediatric paracetamol and amantadine hydrochloride granules〕.METHODS The separation was performed on a C_(18)(150 mm×4.6 mm,5μm)column with the mobile phase of methanol-acetonitrile-1%glacial acetic acid(88∶10∶2),at the flow rate of 1.0 mL·min^(-1).The column temperature was 30℃with the wavelength at 449 nm,and the injection volume was 10μL.RESULTS Bilirubin showed a good linear relationship in the range of 1.221~12.21μg·mL^(-1)(R^(2)=0.9995,n=5).The average recovery rates of the two preparations were 98.0%(RSD was 1.1%,n=6)and 98.6%(RSD was 1.4%,n=6).CONCLUSION The mobile phase of this method is less toxic,simple to obtain,and the test results are accurate and reliable,which can be used for the content determination of bilirubin in pediatric paracetamol,artificial cow-bezoar and chlorphenamine maleate granules,pediatric paracetamol and amantadine hydrochloride granules.

关 键 词：胆红素 小儿氨酚黄那敏颗粒 小儿氨酚烷胺颗粒 高效液相色谱法 

分 类 号：R927[医药卫生—药学]