富马酸酮替芬分散片中有关物质的测定

Determination of Related Substances in Ketotifen Fumarate Dispersible Tablets

目的:建立测定富马酸酮替芬分散片有关物质的方法。方法:采用Kromasil C18色谱柱(150 mm×4.6 mm,5μm),以水-三乙胺(500∶0.175)为流动相A,以甲醇-三乙胺(500∶0.175)为流动相B,进行梯度洗脱,流速为1.0 ml·min-1,检测波长为297 nm,柱温为30℃,进样量为20μl。结果:在该色谱条件下,酮替芬与杂质Ⅰ可完全分离,富马酸酮替芬在0.15~3.00μg·ml-1(以酮替芬计)范围内其线性关系良好(r=1.000 0),在相当于供试品溶液浓度0.01%时的信噪比为5。结论:本法准确,灵敏,可以有效检测富马酸酮替芬分散片的有关物质。

Objective: To establish an HPLC method for the determination of related substances in ketotifen fumarate dispersible tablets. Methods: The column was Kromasil C18( 150 mm×4.6 mm,5 μm) at the temperature of 30℃. The mobile phase A for gradient elution was water-triethylamine( 500 ∶0.175),and methanol-triethylamine( 500 ∶0.175) was used as the mobile phase B. The flow rate was 1.0 ml·min-1,the detection wavelength was 297 nm,and the injection volume was 20 μl. Results: Under the described chromatographic conditions,ketotifen was completely separated from impurityⅠ. The linear response range was 0.15-3.00 μg·ml-1 for ketotifen( r = 1.000 0) and the signal-to-noise ratio for 0.01% test solution was 5. Conclusion: The method is reliable and sensitive. It can be used for determining the related substances in ketotifen fumarate dispersible tablets.