目的 建立同时测定复方盐酸林可霉素滴鼻剂中盐酸林可霉素和利巴韦林的HPLC方法。方法 采用高效液相色谱梯度洗脱法。Shim-pack VP-ODS C₁₈色谱柱(150 mm×4.6 mm, 5 μm);流动相:甲醇-0.05 mol/L四硼酸钠溶液(用磷酸调pH值至6.0);梯度洗脱;柱温:30 ℃;体积流量:1 mL/min;检测波长:210 nm;进样量:10 μL。结果 盐酸林可霉素和利巴韦林分别在0.202 8～2.028 0 μg和0.101 6～1.016 0 μg与峰面积具有良好的线性关系, 平均回收率分别为100.54%、99.95%, RSD值分别为1.11%、1.45%(n=9)。结论 建立的方法简便、灵敏、准确, 为复方林可霉素滴鼻剂的质量控制提供支持。

Objective To establish a method for simultaneous determination of lincomycin hydrochloride and ribavirin in Compound Lincomycin Hydrochloride Nasal Drops. Methods HPLC with gradient elution method was adopted. The determination was performed on Shim-pack VP-ODS C₁₈ column (150 mm × 4.6 mm, 5 μm) with mobile phase consisted of methanol-0.05 mol/L sodium tetraborate (adjusted to pH 6.0 by phosphoric acid) with gradient elution. The detective wavelength was set at 210 nm. The temperature of column was set at 30 ℃. The flow rate was 1.0 mL/min with injection volume of 10 μL. Results There was good linear relationship between peak areas and contents of lincomycin hydrochloride and ribavirin in the range of 0.202 8-2.028 0 μg and 0.101 6-1.016 0 μg. The average recovery was 100.54% and 99.95% with RSD value of 1.11% and 1.45% (n= 9), respectively. Conclusion The method is simple, sensitive, accurate, and can be used for quality control of Compound Lincomycin Hydrochloride Nasal Drops.