HPLC法同时测定盐酸丙卡特罗口服溶液中主成分及3种抑菌剂的含量  

Simultaneous determination of the main components and three preservatives in procaterol hydrochloride oral solution by HPLC

作　　者：蔡琴 高秀容 程智 胡桃敏 徐源 常艳波 CAI Qin;GAO Xiu-rong;CHENG Zhi;HU Tao-min;XU Yuan;CHANG Yan-bo(Traditional Chinese Medical Hospital of Dazu District,Chongqing 402360;Chengdu Medical College,Chengdu 610500;Sichuan Institute for Drug Control,NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation,Chengdu 611731)

机构地区：[1]重庆市大足区中医院,重庆402360 [2]成都医学院,成都610500 [3]四川省药品检验研究院/国家药品监督管理局药物制剂体内外相关性技术研究重点实验室,成都611731

出　　处：《中南药学》2024年第11期3031-3035,共5页Central South Pharmacy

基　　金：国家药典委员会国家药品标准提高课题(No.2021H029)。

摘　　要：目的建立HPLC法同时测定盐酸丙卡特罗口服溶液中主成分盐酸丙卡特罗以及3种抑菌剂(苯甲酸钠、羟苯乙酯、羟苯丁酯)的含量。方法采用CAPCELL PAK MGⅡC_(18)色谱柱(250 mm×4.6 mm,5μm),以0.02 mol·L^(-1)磷酸二氢钠溶液(用磷酸调节pH至3.0)为流动相A,以乙腈为流动相B,柱温为30℃,检测波长为259 nm,进样量为100μL。结果主成分盐酸丙卡特罗及3种抑菌剂均得到较好的分离,盐酸丙卡特罗在0.0503~0.7548μg·mL^(-1)内线性关系良好(r=1.000),A厂家回收率范围为98.92%~101.00%(RSD=0.63%),B厂家回收率范围为101.09%~102.45%(RSD=0.51%);苯甲酸钠在20.4684~307.0262μg·mL^(-1)内线性关系良好(r=0.9996),A厂家回收率范围为100.11%~101.33%(RSD=0.50%),B厂家回收率范围为101.45%~102.24%(RSD=0.32%);羟苯乙酯在0.5091~7.6364μg·mL-1内线性关系良好(r=0.9999),A厂家回收率范围为99.68%~100.70%(RSD=0.33%);羟苯丁酯在0.2648~3.9720μg·mL-1内线性关系良好(r=1.000),A厂家回收率范围为99.24%~100.38%(RSD=0.44%)。结论本法简便,快速,能同时准确测定盐酸丙卡特罗口服溶液中主成分与3种抑菌剂的含量。Objective To establish an HPLC method for the simultaneous determination of the main components and three preservatives(sodium benzonate,ethylparaben and butyl-p-hydroxybenzoate),in procaterol hydrochloride oral solution.Methods A CAPCELL PAK MGⅡC_(18) column(250 mm×4.6 mm,5μm)was used in gradient elution with the mobile phase A of 0.02 mol·L^(-1) sodium dihydrogen phosphate solution(pH was adjusted to 3.0 with phosphoric acid)and the mobile phase B of acetonitrile.The column temperature was 30℃ and the detection wavelength was 259 nm.The injection volume was 100μL.Results The main components in procaterol hydrochloride and the three preservatives were well separated.Procaterol hydrochloride had a good linear relationship within 0.0503~0.7548μg·mL^(-1)(r=1.000),with manufacturer A’s recovery within 98.92%~101.00%(RSD=0.63%),while manufacturer B’s recovery within 101.09%~102.45%(RSD=0.51%).Sodium benzoate had a good linear relationship within 20.4684~307.0262μg·mL^(-1)(r=0.9996),with manufacturer A’s recovery within 100.11%~101.33%(RSD=0.50%),and manufacturer B’s recovery within 101.45%~102.24%(RSD=0.32%).Ethylparaben had a good linear relationship within 0.5091~7.6364μg·mL^(-1)(r=0.9999),with manufacturer A’s recovery within 99.68%~100.70%(RSD=0.33%).The linear relationship of butyl-p-hydroxybenzoate within 0.2648~3.9720μg·mL^(-1) was good(r=1.000),with manufacturer A’s recovery within 99.24%~100.38%(RSD=0.44%).Conclusion The method is simple and accurate,and can be used for the quantification of main components and three preservatives in procaterol hydrochloride oral solution.

关 键 词：盐酸丙卡特罗口服溶液 抑菌剂 高效液相色谱 含量测定 

分 类 号：R927[医药卫生—药学]