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目的:用HPLC法测定复方硫酸锌滴眼液中盐酸小檗碱和尼泊金乙酯的含量。方法:采用Symmetry Shield RP C_(18)色谱柱(250 mm×4.6 mm,5μm);以0.033 mol·L~(-1)磷酸二氢钾(KH_2PO_4)溶液.乙腈(60:40)为流动相,检测波长256 nm。结果:盐酸小檗碱和尼泊金乙酯在线性范围分别为6.3—37.6μg·ml~(-1)(r=0.999 9)和1.9～11.3μg·ml~(-1)(r=0.999 9),平均回收率分别为99.9%(RSD=0.7%)和99.3%(RSD=1.2%)。结论:本方法简便、准确,可用于该制剂中盐酸小檗碱和尼泊金乙酯的含量测定。
Objective: To determine the content of ethyl ester of berberine hydrochloride and paraben in compound zinc sulfate eye drops by HPLC. METHODS: Symmetry Shield RP C 18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was acetonitrile (60:40) with 0.033 mol·L -1 KH 2 PO 4 solution , Detection wavelength of 256 nm. Results: The linear ranges of berberine hydrochloride and paraben were 6.3-37.6μg · ml -1 (r = 0.999 9) and 1.9-11.3μg · ml -1 (r = 0.999 9) with an average recovery of 99.9% (RSD = 0.7%) and 99.3% (RSD = 1.2%), respectively. Conclusion: The method is simple and accurate, and can be used for the determination of ethylparaben hydrochloride and paraben in the preparation.