首页|HPLC法梯度洗脱同时测定曲安奈德益康唑乳膏中4种抑菌剂的含量

HPLC法梯度洗脱同时测定曲安奈德益康唑乳膏中4种抑菌剂的含量

Simultaneous determination of 4 bacteriostatic agents in triamcinolon acetonide econazole cream by HPLC under gradient elution

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目的:建立梯度洗脱HPLC法,以双波长同时测定不同厂家曲安奈德益康唑乳膏中4种抑菌剂含量.方法:采用Waters Symmetry C18(250 mm ×4.6 mm,5 μm)色谱柱,以甲醇为流动相A,以甲醇-0.02 mol·L-1磷酸二氢钠溶液(95∶5)为流动相B,梯度洗脱,流速为1.0 mL·min-1,柱温为35 ℃,检测波长为228 nm、254 nm.结果:本法可有效分离曲安奈德益康唑乳膏中各色谱峰,苯甲酸、羟苯甲酯、羟苯乙酯和羟苯丙酯分别在 0.010 348~0.155 22 mg·mL-1、0.009 876~0.148 145 mg·mL-1、0.010 106~0.151 588 mg·mL-1、0.010 259~0.153 882 mg·mL-1范围内与峰面积线性关系良好;平均回收率(n=9)分别为99.68%(RSD=2.35%)、100.21%(RSD=1.78%)、100.47%(RSD=1.59%)、100.06%(RSD=1.65%),检测限分别为 3 × 10-5 mg·mL-1、1.67 × 10-5 mg·mL-1、1.67 × 10-5 mg·mL-1、1.67 × 10-5 mg·mL-1.结论:本研究建立的曲安奈德益康唑乳膏中抑菌剂的含量测定方法,方法灵敏、准确,色谱峰分离良好,为其质量控制提供了依据.
Objective:To develop an HPLC method with gradient elution for the simultaneous determination of 4 bacteriostatic agents in triamcinolone acetonide econazole cream from the different manufacturers.Methods:The test was performed on a Waters Symmetry C18 column(250 mm ×4.6 mm,5 μm)under gradient elution of metha-nol(A)and methanol-0.02 mol·L-1 sodium dihydrogen phosphate solution(B).The flow rate of 1.0 mL·min-1 and the column temperature was 35 ℃.The detection wavelengths were 228 nm and 254 nm.Results:The good separation of the bacteriostatic agents peaks were achieved.The linear ranges of benzoic acid,methyl hydroxybenzoate,ethylparaben and propylparaben fell into 0.010 348-0.155 22 mg·mL-1,0.009 876-0.148145 mg·mL-1,0.010 106-0.151 588 mg·mL-1 and 0.010 259-0.153 882 mg·mL-1 respectively.The av-erage recoveries were 99.68%(RSD=2.35%),100.21%(RSD=1.78%),100.47%(RSD=1.59%)and 100.06%(RSD=1.65%)respectively.The LODs were 3 × 10-5 mg·mL-1,1.67 × 10-5 mg·mL-1,1.67 × 10-5 mg·mL-1 and 1.67 × 10-5 mg·mL-1 respectively.Conclusion:The established method is sensitive and accurate,and has the good separation.It provides the reliable basis for the quality control of triamcinolone ace-tonide econazole cream.

triamcinolone acetonide econazole creambacteriostatic agentbenzoic acidmethyl hydroxybenzoateethylparabenpropylparaben

李震、刘明鹭、栾曾惠、于玮洁、杨钊

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青岛市食品药品检验研究院,山东青岛 261000

青岛妇女儿童医院,山东青岛 261000

曲安奈德益康唑乳膏 抑菌剂 苯甲酸 羟苯甲酯 羟苯乙酯 羟苯丙酯

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(2)