盐酸林可霉素制剂中对乙酰氨基酚检测方法的研究

Study on Detection Method of Paracetamol Illegally Adulterated into Lincomycin Hydrochloride Preparation

采用Waters AtlantisT3（4.6 mm×250 mm,5μm）C18色谱柱,以磷酸盐缓冲液-甲醇（70∶30）作为流动相进行等度洗脱（流速1.0 m L/min）;采用二极管阵列检测器,检测波长244 nm;进样量20μL,建立盐酸林可霉素制剂中非法添加对乙酰氨基酚检测的高效液相色谱方法。结果表明：对乙酰氨基酚在进样浓度0.02014～0.4028 mg/m L范围内均呈良好线性关系（R2=1.0000）,平均回收率分别为100.15%（盐酸林可霉素注射液）和99.90%（盐酸林可霉素可溶性粉）,检出限为0.01 mg/m L。该方法简便、准确、可行,适用于盐酸林可霉素制剂中非法添加对乙酰氨基酚的检测。

A method was established to detect the paracetamol illegally adulterated into lincomycin hydrochloride preparation by high performance liquid chromatography （HPLC）. It was performed on the Wa- ters Atlantis T3 （4.6 mm × 250 ram, 5 μm） C18 column at 244 nm using PDAD. The mobile phase consisted of phosphate buffered saline and methanol at the volume ratio of 70 ： 30, and its constant flow rate was 1.0 mL/min. The injected volume of sample solution was 20 μL. The results showed that there was good linear re- lation （R2 = 1. 0000 ） between the injection concentrations and the peak areas in the range of 0. 02014 0. 4028 mg/mL. The average recovery rates were 100. 15% from lincomycin hydrochloride injection and 99.90% from lincomycin hydrochloride soluble powder respectively. The detection limit was 0.01 mg/mL. This method is simple, accurate and feasible, so it is suitable for detection of paracetamol illegally adulterated into lincomycin hydrochloride preparations.