药品质量控制
ZHU Xuesong;HUANG Xuejing;LIAO Jing;ZHENG Fang
(1. ABSTRACTObjectiveTo establish a HPLC analysis method for contents determination of norfloxacin, metronidazole and beclomethasone propionate in compound norfloxacin eardrops. MethodsThe kromasil C18 column ( 4.6 mm×250 mm, 5 μm ) was used, the methanolacetonitrile0.025 mol8226;L-1 phosphoric acid solution(adjusted to pH 3.0 with triethylamine)water for injection was applied as mobile phase, and the sample was eluted in gradient. Results The linear ranges of norfloxacin, metronidazole and beclomethasone propionate were at 15.0~150.0 μg8226;mL-1(r=0.999 4), 15.1~151.0 μg8226;mL-1(r=0.999 3)and 2.6 ~ 26.0 μg8226;mL-1(r=0.999 4),respectively, and the average recovery rate (n=9)were 99.5%, 99.7% and 99.5% with RSD as 0.80%, 0.78% and 0.92%,respectively. ConclusionThe method is simple, rapid and sensitivity, which is suitable for the content determination of compound norfloxacin eardrops.