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HPLC法测定克霉唑阴道片中咪唑含量的方法研究 被引量:4

Determination of Imidazole in Clotrimazole Vaginal Tablets by High Performance Liquid Chromatography
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摘要 建立克霉唑阴道片中咪唑的测定方法。采用高效液相色谱法,色谱柱:Phenomenex C18柱(250×4.6 mm,5μm);流动相A:KH2PO4缓冲液,流动相B:甲醇,进行梯度洗脱;柱温:30℃,检测波长:215 nm,流速:1.0 m L/min,进样量:20μL。在该色谱条件下,咪唑峰与溶剂峰以及克霉唑峰等能够有效分离;咪唑在0.02665~1.599μg/m L(r=0.9998)浓度范围内呈良好的线性关系;平均回收率为99.4%(RSD=0.2%,n=6)。该方法准确、可靠、灵敏度高、重复性好,可用于克霉唑阴道片中咪唑含量的测定。 A method for the determination of imidazole in clotrimazole vaginal tablets was established. Highperformance liquid chromatography was carried out, using a Phenomenex C18 column (250x4.6 ram, 5 μm) , with themobile phase of potassium phosphate buffer and methanol by gradient elution. The column temperature was 30 ℃ and thedetection wavelength was 215 nm. The flow rate was 1.0 mL/min and the injection volume was 20 μL. Under thiscondition, the peak of imidazole could be effectively separated from the peak of solvent and the peak of clotrimazole.Imidazole had a good linear relationship within the range of 0. 02665 - 1. 599 txg/mL( r=0. 9998). The average recoverywas 99. 4%, and RSD was 0.2% (n=6). The method was accurate, reliable, sensitive and reproducible, and it could beused for the determination of imidazole in clotrimazole vaginal tablets.
出处 《广州化工》 CAS 2017年第18期92-94,共3页 GuangZhou Chemical Industry
关键词 高效液相色谱法 克霉唑阴道片 咪唑 clotrimazole vaginal tablets : imidazole: HPLC
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