HPLC测定萘敏维滴眼液中盐酸萘甲唑林和马来酸氯苯那敏的含量

RP-lP-HPLC Determination of Naphazoline Hydrochloride and Chlorphenamine Maleate in Naphazoline Hydrochloride,Chlorphenamine Maleate and Vitamin B_(12) Eye Drops

目的建立反相离子对高效液相色谱法同时测定萘敏维滴眼液中盐酸萘甲唑林和马来酸氯苯那敏的含量。方法色谱柱:Kromasil ODS(4.6mm×250mm,5μm),流动相:辛烷磺酸钠枸橼酸溶液(取辛烷磺酸钠2.23g,枸橼酸3.8g,加水1000ml溶解,用2mol·L-1氢氧化钠溶液调节pH值至3.0)一乙腈(65∶35),流速:1.0ml·min-1,检测波长:280nm,柱温:40℃。结果线性范围:盐酸萘甲唑林为5.12μg·ml-1～51.2μg·ml-1,r=0.999,马来酸氯苯那敏为50.16μg·ml-1～501.6μg·ml-1,r=0.999。平均回收率分别为99.9%(RSD=0.7%,n=9)和100.0%(RSD=0.6%,n=9)。结论该方法简便、准确、重现性好。可用来测定本品中盐酸萘甲唑林和马来酸氯苯那敏的含量。

Objective To establish a method for the determination of Naphazoline Hydrochloride and Chlorphenamine Maleate in Naphazoline Hydrochloride,Chlorphenamine Maleate and Vitamin B12 Eye Drops by RP-IP-HPLC.Methods The chromatographic column was KromasilC18（4.6mm×250mm,5μm）.The mobile phase was Sodium Octanesulfonate Citric Acid Solution（Sodium Octanesulfonate 2.23g,Citric Acid 3.8g,add water to 1 000ml and adjusted pH 3.0 with 2mol·L-1 Sodium Hydroxide Solution）-acetonitrile（65∶35）,and a flow rate was1.0ml·min^-1 min ; the detec-ting wavelength was 280nm and the column temperature was 40℃. Results The linear range of Nap- hazoline Hydrochloride was 5.12μg·ml^-1 - 51.2 μg · ml^-1 （ r = 0. 999 ）, and the linear range of Chlorphenamine Maleate was 50. 16μg ·ml^-1 - 501.6μg · ml^-1（ r =0. 999） ,The average recovery of Naphazoline Hydrochloride and chlorphenamine Maleate were 99.9% （ n = 9, RSD = 0. 7% ） and 100. 0% （ n = 9, RSD = 0. 6）. Conclusion The method is simple, reliable, accurate and very suitable, which can be used for the content determination of Naphazoline Hydrochloride and Chlorphenamine Maleate in Naphazoline Hydrochloride, Chlorphcnamine Maleate and Vitamin B12 Eye Drop.