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目的:采用RP-HPLC法同时测定复方加替沙星滴耳液中加替沙星和丙酸倍氯米松的含量。方法:Kromasil C_(18)柱(250mm×4.6 mm,5μm),流动相为甲醇(A)-0.05%三乙胺溶液(用冰醋酸调pH至3.0)(B),梯度洗脱,流速0.7 ml·min~(-1),检测波长293 nm,242nm。结果:加替沙星和丙酸倍氯米松的线性范围分别为10.0～80.0μg·ml~(-1)(r=0.999 4)和2.5～20.0μg·ml~(-1)(r=0.999 3),平均回收率为100.3%和100.5%,RSD分别为0.61%和0.40%(n=9)。结论:方法准确,可以有效地控制复方加替沙星滴耳液的质量。
Objective: To determine the contents of gatifloxacin and beclomethasone dipropionate in compound gatifloxacin ear drops by RP-HPLC. METHODS: Kromasil C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol (A) -0.05% triethylamine (adjusted to pH 3.0 with glacial acetic acid) (B) ml · min ~ (-1). The detection wavelength was 293 nm and 242 nm. RESULTS: The linear range of gatifloxacin and beclomethasone was 10.0 ~ 80.0μg · ml -1 (r = 0.999 4) and 2.5 ~ 20.0μg · ml -1 (r = 0.999 3) with mean recoveries of 100.3% and 100.5% with RSDs of 0.61% and 0.40%, respectively (n = 9). Conclusion: The method is accurate and can effectively control the quality of compound gatifloxacin ear drops.