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目的:建立测定加替沙星醋酸地塞米松滴耳液中药物含量的HPLC法。方法:色谱柱为菲罗门C18柱(250 mm×4.6 mm,5μm),流动相A为甲醇,B为0.05%三乙胺溶液(冰醋酸调节pH至3.0),进行梯度洗脱,流速为1.0 ml·min-1;柱温为30℃;检测波长为240 nm。结果:加替沙星质量浓度在1.2~60.0 mg·L-1范围内,醋酸地塞米松质量浓度在0.8~40.0mg·L-1范围内与峰面积呈良好的线性关系,平均回收率分别为101.31%(RSD=1.17%)和99.71%(RSD=1.01%)。结论:该方法对两种药物分离效果较好,辅料无干扰,专属性强、稳定可靠,适用于替加沙星醋酸地塞米松滴耳液中的药物含量测定。
Objective: To establish a HPLC method for the determination of gatifloxacin acetate dexamethasone ear drops. METHODS: The HPLC-MS was performed on a Phenomenex C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase A of methanol and a 0.05% triethylamine solution (adjusted to pH 3.0 with glacial acetic acid) by gradient elution at a flow rate of 1.0 ml · min-1; column temperature was 30 ℃; detection wavelength was 240 nm. Results: The concentration of gatifloxacin in the range of 1.2-60.0 mg · L-1, dexamethasone acetate mass concentration in the range of 0.8-40.0 mg · L-1 showed a good linear relationship with the peak area, the average recovery rates 101.31% (RSD = 1.17%) and 99.71% (RSD = 1.01%). Conclusion: The method has good separation effect on two drugs, non-interference accessories, strong specificity, stable and reliable, and is suitable for the determination of drug content of tegaserod acetate in dexamethasone ear drops.