高效液相色谱法同时测定肺力咳合剂中苯甲酸钠等6种防腐剂含量  

Simultaneous Determination of 6 Kinds of Preservatives Including Sodium Benzoate in Feilike Mixture by High Performance Liquid Chromatography

作　　者：唐川[1] 沈学彬 桂凌[1] Tang Chuan;Shen Xuebin;Gui Ling(The People’s Hospital of Chizhou,Anhui Chizhou 247000,China)

机构地区：[1]池州市人民医院,安徽池州247000

出　　处：《儿科药学杂志》2022年第9期26-29,共4页Journal of Pediatric Pharmacy

摘　　要：目的:建立高效液相色谱(HPLC)同时测定肺力咳合剂中苯甲酸钠等6种防腐剂含量的方法。方法:采用HPLC法,色谱柱:Agilent XDB-C_(18)色谱柱(250 mm×4.6 mm,5μm),流动相:甲醇-0.025 mol/L磷酸二氢钠溶液(梯度洗脱);流速:1.0 mL/min;柱温30℃,检测波长228 nm、255 nm。结果:肺力咳合剂中苯甲酸钠在0.06354~211.80000μg(r=0.9999)、山梨酸钾在0.06606~220.20000μg(r=0.9999)、对羟基苯甲酸甲酯在0.06270~209.00000μg(r=0.9999)、对羟基苯甲酸乙酯在0.06612~220.40000μg(r=0.9999)、对羟基苯甲酸丙酯在0.06798~226.60000μg(r=0.9999)、对羟基苯甲酸丁酯在0.06330~211.00000μg(r=0.9999)范围内线性良好,平均回收率分别为100.72%(RSD=0.82%)、104.82%(RSD=1.59%)、101.11%(RSD=0.25%)、102.39%(RSD=1.33%)、102.56%(RSD=1.35%)、101.09%(RSD=0.34%)。10批样品中均未检出山梨酸钾、对羟基苯甲酸甲酯、对羟基苯甲酸丁酯,苯甲酸钠、对羟基苯甲酸乙酯、对羟基苯甲酸丙酯的含量分别为2.1326~2.6026 mg/mL、0.1108~0.1260 mg/mL、0.3999~0.4089 mg/mL。结论:该方法具有操作简单、专属性强、准确度高的优点,可以更全面地控制肺力咳合剂中防腐剂的含量。Objective:To establish the method for simultaneous determination of 6 preservatives including sodium benzoate in Feilike mixture by high performance liquid chromatography(HPLC).Methods:HPLC was performed on Agilent XDB-C_(18) column(250 mm×4.6 mm,5μm)with mobile phase of methanol-0.025 mol/L sodium dihydrogen phosphate solution(gradient elution).The flow rate was 1.0 mL/min.The column temperature was 30℃,and the detection wavelength was 228 nm and 255 nm.Results:There were good linearity in the range from 0.063,54 to 211.800,00μg(r=0.999,9)for sodium benzoate,from 0.066,06 to 220.200,00μg(r=0.999,9)for potassium sorbate,from 0.062,70 to 209.000,00μg(r=0.999,9)for methyl p-hydroxybenzoate,from 0.066,12 to 220.400,00μg(r=0.999,9)for ethyl p-hydroxybenzoate,from 0.067,98 to 226.600,00μg(r=0.999,9)for propyl p-hydroxybenzoate,from 0.063,30 to 211.000,00μg(r=0.999,9)for butyl p-hydroxybenzoate.The average recoveries were 100.72%(RSD=0.82%),104.82%(RSD=1.59%),101.11%(RSD=0.25%),102.39%(RSD=1.33%),102.56%(RSD=1.35%)and 101.09%(RSD=0.34%),respectively.Sodium benzoate,methyl p-hydroxybenzoate and butyl p-hydroxybenzoate were not detected in 10 batches of samples,and the contents of sodium benzoate,ethyl p-hydroxybenzoate and propyl p-hydroxybenzoate were respectively from 2.132,6 to 2.602,6 mg/mL,from 0.110,8 to 0.126,0 mg/mL,from 0.399,9 to 0.408,9 mg/mL.Conclusion:The method has the advantages of simple operation,strong specificity and high accuracy,and can comprehensively control the content of preservatives in Feilike mixture.

关 键 词：肺力咳合剂 苯甲酸钠 山梨酸钾 对羟基苯甲酸甲酯 对羟基苯甲酸乙酯 对羟基苯甲酸丙酯 对羟基苯甲酸丁酯 含量测定 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]