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目的建立测定马来酸非尼拉敏盐酸萘甲唑啉滴眼液中马来酸非尼拉敏含量的RP-HPLC法。方法采用Agilent C_(18)(150 mm×4.6mm,5μm)色谱柱,流动相:V[乙酸缓冲液(0.1 mol·L~(-1)乙酸铵,0.5%三乙胺,乙酸调pH至4.0)]:V(甲醇)=97:3,柱温20℃,流速1 mL·min~(-1),检测波长262 nm。外标法计算含量。结果在该色谱条件下,马来酸非尼拉敏线性良好(r>0.999,n=7),加样回收率为97%～103%(n=3),RSD<2.0%(n=3)。样品在24 h内稳定。测得样品含量合格,为97%～103%。结论本方法简便快速,所测结果准确可靠,重复性好。
OBJECTIVE To establish a RP-HPLC method for the determination of phenylephrine maleate in nifedipine maleate eye drops. Methods Agilent C 18 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of V [acetate buffer (0.1 mol·L -1 ammonium acetate, 0.5% triethylamine, 4.0)]: V (methanol) = 97: 3, the column temperature was 20 ℃, the flow rate was 1 mL · min -1 and the detection wavelength was 262 nm. External standard calculation of content. Results Under the chromatographic conditions, the linearity of the phenylephrine maleate was good (r> 0.999, n = 7) and the recoveries were 97% ~ 103% (n = 3) ). The sample is stable within 24 h. Measured sample content passed, 97% ~ 103%. Conclusion The method is simple and rapid, the test results are accurate and reliable, good repeatability.