高效液相色谱法同时测定乙酰半胱氨酸口服溶液中乙酰半胱氨酸及抑菌剂含量  

Simultaneous Determination of Acetylcysteine and Bacteriostatic Agents in Acetylcysteine Oral Solution by HPLC Method

作　　者：樊艳霞 吴小强 牟立燕 赵玉涵 康越 FAN Yanxia;WU Xiaoqiang;MOU Liyan;ZHAO Yuhan;KANG Yue(Jilin Provincial Institute for Drug Control and Research,Jilin Changchun 130000,China;Changchun Lanjiang Pharmaceutical Technology Co.,Ltd.,Jilin Changchun 130000,China)

机构地区：[1]吉林省药品检验研究院,吉林长春130000 [2]长春澜江医药科技有限公司,吉林长春130000

出　　处：《中国医药导刊》2024年第9期902-908,共7页Chinese Journal of Medicinal Guide

摘　　要：目的:建立同时测定乙酰半胱氨酸口服溶液中乙酰半胱氨酸及抑菌剂苯甲酸钠、羟苯甲酯的高效液相色谱(HPLC)分析方法。方法:HPLC色谱柱Ultimate LP-C18(4.6 mm×250 mm,5µm),以0.1%磷酸溶液为流动相A,以0.1%磷酸乙腈溶液为流动相B,进行梯度洗脱;流速为1.0 mL·min^(-1);检测波长为215 nm;柱温为30℃;进样体积10µL。结果:乙酰半胱氨酸、苯甲酸钠、羟苯甲酯的定量限浓度分别为0.00357、0.00023、0.00012 mg·mL^(-1),检测限浓度分别为0.00119、0.00008、0.00004,分别在0.499~1.496、0.038~0.113、0.025~0.075 mg·mL^(-1)浓度范围内呈良好线性关系(r≥0.9999),平均回收率(n=12)分别为99.6%(RSD=0.934%)、100.3%(RSD=0.909%)、99.7%(RSD=1.837%)。结论:所建立的HPLC法简便高效、结果准确、重复性好,可用于测定乙酰半胱氨酸口服溶液中乙酰半胱氨酸及抑菌剂的含量。Objective:To develop an HPLC method for simultaneous determination of acetylcysteine,sodium benzoate and methylparaben in acetylcysteine oral solution.Methods:The analytical experiment was performed on Ultimate LP-C18 column(4.6 mm×250 mm,5µm)with 0.1%phosphate acid solution as mobile phase A and 0.1%phosphate acetonitrile solution as mobile phase B.Gradient elu-tion was performed at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 215 nm.The column temperature was 30℃,and the injection volume was 10µL.Results:The quantitation limit concentration of acetylcysteine,sodium benzoate,methylparaben respectively was 0.00357,0.00023,0.00012 mg·mL^(-1).The detection limit concentration respectively was 0.00119,0.00008,0.00004 mg·mL^(-1).The linear ranges for acetylcysteine,sodium benzoate,methylparaben were 0.499-1.496,0.038-0.113,0.025-0.075 mg·mL^(-1)(r≥0.9999).The average recovery was 99.6%(RSD=0.934%),100.3%(RSD=0.909%),and 99.7%(RSD=1.837%)(n=12),respectively.Conclusion:The established HPLC method is simply operable,efficient,accurate and reproducible,which could be used for the quantitative determination of acetylcysteine and bateriostatic agents in acetylcysteine oral solution.

关 键 词：乙酰半胱氨酸 苯甲酸钠 羟苯甲酯 HPLC 

分 类 号：R927.2[医药卫生—药学]