高效液相色谱法同时测定复方硫酸新霉素滴眼液中3种成分含量  

Simultaneous Determination of Three Constituents in Compound Neomycin Sulfate Eye Drops by HPLC

作　　者：赵猛 李玲 ZHAO Meng;LI Ling(Lianyungang Institute for Food and Drug Control,Lianyungang,Jiangsu,China 222000)

机构地区：[1]江苏省连云港市食品药品检验检测中心,江苏连云港222000

出　　处：《中国药业》2021年第10期65-67,共3页China Pharmaceuticals

摘　　要：目的建立同时测定复方硫酸新霉素滴眼液中肌苷、羟苯乙酯和地塞米松磷酸钠含量的高效液相色谱法。方法色谱柱为Phenomenex Gemini C18柱(150 mm×4.6 mm,5μm),流动相为1%三乙胺溶液(用磷酸调pH至3.0)-甲醇(梯度洗脱),流速为1.0 m L/min,检测波长为248 nm,柱温为25℃,进样量为50μL。结果肌苷、羟苯乙酯和地塞米松磷酸钠进样量在2.525~7.575μg、1.055~3.160μg、2.510~7.535μg范围内与峰面积线性关系良好(r>0.9990),精密度、稳定性、重复性试验的RSD均小于2.0%(n=6),平均加样回收率分别为98.80%,99.50%,98.38%,RSD分别为0.74%,1.46%,1.23%(n=6)。结论该方法简单、准确、稳定,可用于同时测定复方硫酸新霉素滴眼液中肌苷、羟苯乙酯和地塞米松磷酸钠3种成分的含量。Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneous determination of inosine,ethylparaben and dexamethasone sodium phosphate in Compound Neomycin Sulfate Eye Drops.Methods The chromatographic column was Phenomenex Gemini C18 column(150 mm×4.6 mm,5μm),the mobile phase was 1%triethylamine(adjusted pH to 3.0 with phosphoric acid)-methanol(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 248 nm,the column temperature was 25℃,and the injection volume was 50μL.Results The linear ranges of inosine,ethylparaben and dexamethasone sodium phosphate were 2.525-7.575μg,1.055-3.160μg and 2.510-7.535μg(r>0.9990).RSDs of the precision,stability and repeatability tests were all less than 2.0%(n=6),the average recoveries of inosine,ethylparaben and dexamethasone sodium phosphate were 98.80%(RSD=0.74%,n=6),99.50%(RSD=1.46%,n=6),98.38%(RSD=1.23%,n=6),respectively.Conclusion The method is simple,accurate,stable,which can be used for the simultaneous determination of inosine,ethylparaben and dexamethasone sodium phosphate in Compound Neomycin Sulfate Eye Drops.

关 键 词：高效液相色谱法 复方硫酸新霉素滴眼液 肌苷 羟苯乙酯 地塞米松磷酸钠 含量测定 

分 类 号：R927.2[医药卫生—药学] R988.1