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目的建立高效液相色谱法测定氟康唑莫西沙星眼用即型凝胶含量,同时测定制剂中氟康唑、莫西沙星和羟苯乙酯的含量。方法采用ODS-C18色谱柱,以三乙胺缓冲液-甲醇为流动相,流速1.0 mL.min 1,检测波长260 nm。结果氟康唑、莫西沙星、羟苯乙酯的线性范围分别为25～250 g.mL 1(r=0.999 9,n=6),25～250 g.mL 1(r=0.999 9,n=6),2.5～25 g.mL 1(r=0.999 7,n=6),平均回收率分别为99.6%,99.4%,99.3%。RSD分别为1.23%,1.20%,1.17%。结论本方法操作简便,灵敏度高,重复性好,可用于该制剂的含量测定。
OBJECTIVE To establish HPLC method for the determination of moxifloxacin ophthalmic gel, and to determine the content of fluconazole, moxifloxacin and hydroxyphenol in the preparation. Methods ODS-C18 column was used with mobile phase of triethylamine buffer and methanol as the mobile phase at a flow rate of 1.0 mL · min 1 with a detection wavelength of 260 nm. Results The linear range of fluconazole, moxifloxacin and phenethyl was 25 ~ 250 g.mL 1 (r = 0.999 9, n = 6), 25 ~ 250 g.mL 1 = 6) and 2.5 ~ 25 g.mL 1 (r = 0.999 7, n = 6). The average recoveries were 99.6%, 99.4% and 99.3%, respectively. RSD were 1.23%, 1.20% and 1.17% respectively. Conclusion The method is simple, sensitive, reproducible and can be used for the determination of the content of the preparation.