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目的 :建立测定鼻眼净滴鼻剂中盐酸萘甲唑林含量的高效液相色谱法。方法 :采用HypersilBDSC18(5 μm ,4mm× 15 0mm)色谱柱 ,以甲醇 0 .0 5mol·L-1硫酸铵 (5 0∶5 0 )为流动相 ,紫外检测波长 2 81nm ,外标法定量。结果 :盐酸萘甲唑林浓度在 0 .5～ 2 0 μg·ml-1范围内呈线性关系 ,方法回收率为 99.2 % (n =6 ) ,RSD为 0 .5 %。结论 :此法避免了羟苯乙酯的干扰 ,灵敏度高 ,重现性好 ,结果准确 ,适用于该制剂的质量控制
Objective: To establish a HPLC method for the determination of naphthalene hydrochloride in nasal eye drops nasal drops. METHODS: Hypersil BDSC18 (5 μm, 4 mm × 150 mm) column was used. The mobile phase consisted of methanol with 0.05 mol·L-1 ammonium sulfate (50:50) as the mobile phase. The UV detection wavelength was 2 81 nm. Results: The concentration of naphazoline hydrochloride in the range of 0.5 ~ 20 μg · ml-1 showed a linear relationship with the recovery of 99.2% (n = 6) and RSD of 0.5%. Conclusion: This method avoids the interference of HPPH, high sensitivity, good reproducibility, accurate results, suitable for the quality control of the preparation