摘要
目的建立用HPLC法测定色甘那敏滴眼液中色甘酸钠和马来酸氯苯那敏含量的方法。方法采用C18柱。以醋酸钠缓冲溶液-甲醇(67:33)和(55:45)为流动相,分别测定色甘酸钠和马来酸氯苯那敏的含量,检测波长分别为325 nm和261 nm;流速为1.0 ml/min。结果色甘酸钠在21.6～539.6μg/ml(r=0.999 9)范围内,马来酸氯苯那敏在11.5～287.2μg/ml(r=0.999 8)范围内与峰面积呈良好的线性关系,平均回收率分别为99.97%和100.03%,RSD分别为0.34%和0.54%。结论该方法可用于测定色甘那敏滴眼液中色甘酸钠和马来酸氯苯那敏的含量。
Objective To establish a HPLC method for the determination of sodium cromoglicate and chlorphenamine maleate in eye drops. Methods A C18 column was used with the mobile phase consisting of a mixture of sodium acetate buffer solution and methanol （67：33） for the determination of sodium cromoglicate at the flow rate of 1.0 ml/min and detection wavelength of 325nm. The determination of ehlorphenamine maleate was also done on C18 column with the mobile phase consisting of a mixture of sodium acetate buffer solution and methanol （55：45） at the flow rate of 1.0 ml/min and detection wavelength of 261nm. Results For sodium cromoglicate, the standard curve was linear in the range from 21.6 μg/ml to 539.6 μg/ml （γ=0.999 9） and the average recovery was 99.97% （RSD =0.34%）. For chlorphenamine maleate, the standard curve was linear in the range from 11.5 μg/ml to 287. 2 μg/ml （γ=-0.999 8） and the average recovery was 100.03% （RSD =0.54%）. Conclusion The method is suitable for determining the contents of sodium eromoglicate and chlorphenamine maleate in eye drops.
出处
《食品与药品》
CAS
2006年第07A期49-51,共3页
Food and Drug
