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HPLC-DAD法测定康复新液中10种抑菌剂含量

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目的:建立同时测定康复新液中10种抑菌剂的高效液相色谱分析方法。方法:采用Thermo AcclaimTM 120(4。6 mm ×250 mm,5 μm)色谱柱,流动相为0。1%冰醋酸-0。02 mol·L-1乙酸铵溶液和甲醇,梯度洗脱,流速为1 mL·min-1,扫描波长为200~700 nm。结果:在相应的浓度范围内,10种抑菌剂质量浓度与峰面积的线性关系良好,r≥0。999 8;精密度试验良好,RSD在0。33%~0。38%;重复性试验与稳定性试验的RSD<0。5%,加标回收范围为97。4%~101。1%,RSD在0。4%~1。8%之间。按拟定方法测试样品苯甲酸含量在0。15%~0。34%范围,山梨酸含量在0~0。48%范围,羟苯乙酯含量在0~0。02%范围、羟苯丙酯含量再0~0。02%范围。结论:该方法灵敏快速、专属性强、准确度高,可用于康复新液中抑菌剂的含量测定。
Determination of ten bacteriostatic agents in Kangfuxin Solution by HPLC-DAD method
Objective:To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of 10 bacteriostatic agents in Kangfuxin solution.Methods:The HPLC method parameters were as follows,a Thermo AcclaimTM 120 column(4.6 mm × 250 mm,5 μm),a gradient mobile phase of 0.1%glacial acetic acid-0.02 mol·L-1 ammonium acetate solution and methanol at a flow rate of 1 mL·min-1,and the scan-ning wavelength of 200-700 nm.Results:In the corresponding concentration range,the linear relationship be-tween the mass concentration of the 10 bacteriostatic agents and the peak area was good(r≥0.999 8);the preci-sion was good with RSD of 0.33%-0.38%;The RSD values of the repeatability test and the stability test were<0.5%,the recovery rate was 97.4%-101.1%,and the RSD was between 0.4%-1.8%.According to the pro-posed method,the content results of benzoic acid,sorbic acid,hydroxyphenyl ethyl ester and hydroxyphenyl propyl ester in the test sample were 0.15-0.34%,0-0.48%,0-0.02%,and 0-0.02%,respectively.Conclu-sion:This method is sensitive,rapid,specific and accurate,and can be used for the determination of the content of bacteriostatic agents in Kangfuxin solution.

kangfuxin solutionHPLC-DADbacteriostatic agentbenzoic acidsorbic acidmethyl 4-hydroxy-benzoatechlorhexidine acetate

张万青、郑文燕、王彩媚、乔莉、刘潇潇

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广东省药品检验所,广州 510700

康复新液 HPLC-DAD 抑菌剂 苯甲酸 山梨酸 羟苯甲酯 醋酸氯己定

2024

中国药品标准
国家药典委员会

中国药品标准

影响因子:0.372
ISSN:1009-3656
年,卷(期):2024.25(3)