HPLC法测定盐酸林可霉素注射液中林可霉素的含量

Content determination of lincomycin in lincomycin hydrochlorde injection by HPLC

关键词:  盐酸林可霉素注射液  含量测定  高效液相色谱法

Key words:  lincomycin hydrochlorde injection  content  high performance liquid chromatography(HPLC)

摘要:

建立并验证了高效液相色谱法测定盐酸林可霉素注射液中林可霉素含量的方法。试验采用十八烷基硅烷键合硅胶色谱柱（4.6 mm ? 250 mm，5 μm），以0.02mol/L磷酸氢二铵-乙腈（75:25, v/v）为流动相，流速为1.0 mL/min，柱温为30℃，波长为214 nm。试验结果表明林可霉素在0.2～4.0 mg/mL范围内线性良好，R2=1.0000，平均回收率为100.2%（n=9），RSD为0.6%。与《中国兽药典》2015年版一部收载的方法相比，本文开发的方法优化了流动相，使流动相含盐量大大降低，林可霉素峰形更尖锐，理论板数更高。本方法简便、准确、可靠可用于盐酸林可霉素注射液的质量控制。

Abstract:

The method for content determination of lincomycin in lincomycin hydrochlorde injection by HPLC was developed and validated. Analysis was performed on a C18 column (4.6 mm × 250 mm, 5 μm) with a mobile phase of 0.02 mol/L diammonium phosphate aqueous solution – acetonitrile (75:25, v/v) at a flow rate of 1.0 mL/min and a column temperature of 30℃. The determination wave length was 214 nm. The results showed that a good linear relationship was accepted in the range of 0.2～4.0 mg/mL (R2=1.0000), and the average recovery was 100.2% (n=9)with RSD% of 0.6%. In contrast with method in Chinese veterinary pharmacopoeia 2015, the mobile phase was optimized by reducing salinity while the peak shape and number of theoretical plates of lincomycin were improved. This method was convenient, accurate, reliable and was suitable to control the quality of lincomycin hydrochlorde injection.