盐酸林可霉素注射液的含量测定方法的改进

Improvement of the content determination method of lincomycin hydrochloride injection in veterinary pharmacopoeia of People’s Republic of China 2015 Edition

建立并验证HPLC法测定盐酸林可霉素注射液的含量方法。采用十八烷基硅烷键合硅胶色谱柱(4.6 mm×250 mm,5μm),以磷酸溶液-乙腈-甲醇(80∶15∶15)为流动相,流速为1.0 mL/min,柱温为40℃,波长210 nm。试验结果表明,盐酸林可霉素在0.1~4.0 mg/mL范围内线性良好,R=0.999 9,平均回收率为98.8%(n=9),RSD为1.0%。该方法与《中华人民共和国兽药典》2015年版一部中的HPLC法比较,可减少盐溶液对色谱柱的污染,提高色谱系统的稳定性、灵敏度及被测色谱峰的理论塔板数,同时流动相配置方便、快速,适用于盐酸林可霉素注射液的质量控制。

The determination method of lincomycin in lincomycin hydrochloride 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 phosphorous acid solution-acetonitrile-methanol(80∶15∶15) with a 1.0 m L/min flow rate in 40 ℃condition. The determination wave length was 210 nm.The results showed that the calibration curve was linear in the range of 2~100 μg/mL(R=0.999 9),and the average recovery was 98.1%(n =9) with RSD of 1.0%.In contrast with the method in Pharmacopoeia of People′ s Pepublic of China volumeⅠ2015 editon. The method reduce the pollution of salt solution to chromatographic column,Improve the stability and sensitivity of the chromatographic system,Improve thetheoretical plate number of the measured chromatographic peak. This method was convenient,rapid,and accurate,which was suitable to control the quality of Lincomycin Hydrochloride Injection.