目的 建立同時(shí)測(cè)定復(fù)方鹽酸林可霉素滴鼻劑中鹽酸林可霉素和利巴韋林的HPLC方法。方法 采用高效液相色譜梯度洗脫法。Shim-pack VP-ODS C₁₈色譜柱(150 mm×4.6 mm, 5 μm);流動(dòng)相:甲醇-0.05 mol/L四硼酸鈉溶液(用磷酸調(diào)pH值至6.0);梯度洗脫;柱溫:30 ℃;體積流量:1 mL/min;檢測(cè)波長(zhǎng):210 nm;進(jìn)樣量:10 μL。結(jié)果 鹽酸林可霉素和利巴韋林分別在0.202 8～2.028 0 μg和0.101 6～1.016 0 μg與峰面積具有良好的線性關(guān)系, 平均回收率分別為100.54%、99.95%, RSD值分別為1.11%、1.45%(n=9)。結(jié)論 建立的方法簡(jiǎn)便、靈敏、準(zhǔn)確, 為復(fù)方林可霉素滴鼻劑的質(zhì)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.