林可霉素注射液非法添加盐酸左旋咪唑的HPLC检测方法研究

Study on Detection Method of Levamisole Hydrochloride Illegally Adulterated into Lincomycin injection

关键词:  林可霉素注射液  左旋咪唑  检测

Key words:  lincomycin injection  levamisole  detect

摘要:

建立了兽用林可霉素注射液中非法添加盐酸左旋咪唑的高效液相色谱检测方法。采用Waters Atlantis? T3 C18(4.6×250mm, 5μm)色谱柱分离，以磷酸二氢钠溶液-甲醇(70:30)作为流动相进行等度洗脱（流速1.00mL/min），用二极管阵列检测器在230nm波长处进行测定。考察了此色谱条件下方法的专属性、线性、回收率、精密度、检测限和耐用性。结果表明，盐酸左旋咪唑在进样浓度为0.02mg/mL～0.4mg/mL时呈良好的线性关系，R2=0.9999；重复性试验RSD为0.6%；平均回收率为99.7%；检测限为 0.0002mg/mL，定量限为0.0016mg/mL。该法准确、简便、可行，适用于林可霉素注射液中盐酸左旋咪唑的检测。

Abstract:

A method was established to detect the levamisole hydrochloride adulterated into veterinary lincomycin hydrochloride injection by high performance liquid chromatography (HPLC). Isocratic elution was used with the mobile phase consisted of sodium dihydrogen phosphate buffered saline solution and methanol at the volume ratio of 70:30, and its constant flow rate was 1.00mL/min. It was performed on the Waters Atlantis? T3 (4.6×250mm, 5μm) C18 column at 230nm by diode-array detector. Specificity, linear relation, recovery, precision, detection limit and durability were investigated under the chromatographic condition. The results showed that there was good linear relation between the levamisole hydrochloride concentrations and peak areas in the range of 0.02mg/mL～0.4mg/mL，R2=0.9999. The RSD of precision was 0.6%. The average recovery rate was 99.7%. Limit of detection was 0.0002mg/mL, limit of quantatation is 0.0016mg/mL. This method is simple, accurate, feasible, so it is suitable for detection of levamisole hydrochloride which is illegally adulterated into lincomycin injection.