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机构地区:[1]河南省食品药品检验所,郑州450003 [2]河南省药品审评认证中心,郑州450004
出 处:《中国药房》2014年第12期1134-1136,共3页China Pharmacy
摘 要:目的:建立测定曲安奈德益康唑乳膏中有关物质的方法。方法:采用高效液相色谱法。色谱柱为Venusil ASB C18流动相A、B分别为甲醇.0.077%醋酸铵溶液(20:80,V/V,磷酸调节pH至4.5)和甲醇.乙腈(40:60,V/V),梯度洗脱,流速为1.0ml/min,检测波长为225m,柱温为35℃,进样量为10μl。结果:曲安西龙、硝酸咪康唑以及3个单个未知杂质均能与曲安奈德益康唑乳膏中的主成分完全分离;曲安西龙、硝酸咪康唑的检测质量浓度分别在1.071~8.568、1.039-8.312μg/ml范围内与各自峰面积积分值呈良好的线性关系(r=0.9998、0.9996),检测限分别为5.15、7.31ng,定量限分别为15.69、21.97ng。结论:该方法灵敏、准确、专属性强、重复性好,可用于曲安奈德益康唑乳膏的质量控制。OBJECTIVE: To establish a method for the content determination of related substances in Triamcinolone acetonide and econazole nitrate cream. METHODS: HPLC method was adopted. The determination was performed on Venusil ASB C18 column with mobile phase A composed of methanol-0.077% ammonium acetate (20: 80, VIV, pH value adjusted to 4.5 using phosphoric acid) and methanol-acetonitrile (40: 60, V/V) as mobile phase B (gradient elution) at the flow rate of 1.0 ml/min, The detection wavelength was 225 nm, and the column temperature was 35 ℃. The sample size was 1 0 μl. RESULTS: Fluoxyprednisolone and miconazole nitrate and unknown impurity were completely separated from main components of Triamcinolone acetonide and econazole nitrate cream. The linear range of 2 kinds of known impurities were 1.071-8.568 μg/ml(r=0.999 8) and 1.039-8.312 μg/ml (r=0.999 6). The detection limits were 5.15 ng and 7.31 ng , and quantitative limits were 15.69 ng and 21.97 ng. CONCLUSIONS: The method is sensitive, accurate specific and reproducible, which can be used for the quality control of related substance in Triamcinolone acetonide and econazole nitrate cream.
关 键 词:高效液相色谱法 梯度洗脱 曲安奈德益康唑乳膏 有关物质
分 类 号:R917[医药卫生—药物分析学]
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