高效液相色谱法测定左旋四氢巴马汀自微乳中左旋四氢巴马汀含量  

Content Determination of L-Tetrahydropalmatine in L-Tetrahydaopalmatine Self-Microemulsion by HPLC

作　　者：梁淑贞[1] 丁少波[1] 钟李青[1] 何瑞荣[1] 

机构地区：[1]广东省东莞市人民医院药学部,广东东莞523000

出　　处：《中国药业》2017年第1期28-30,共3页China Pharmaceuticals

摘　　要：目的建立测定左旋四氢巴马汀自微乳含量的高效液相色谱法。方法色谱柱采用Phenomenex Desc Gemini-NX 5μC18柱(250 mm×4.6 mm,5μm,110),流动相为0.1%磷酸溶液(三乙胺调p H至6.32)-甲醇(35∶65),检测波长为280 nm,进样量为10μL,流速为1.0 m L/min,柱温为30℃。结果左旋四氢巴马汀质量浓度在0.1~1.0 g/L范围内与峰面积线性关系良好(r=0.999 9);精密度试验RSD为0.38%;稳定性试验RSD为0.96%;重复性试验左旋四氢巴马汀的含量为91.81%,RSD为0.58%;回收试验平均回收率为99.97%,RSD为0.60%(n=9)。结论该方法简便、灵敏、重复性好,结果准确、可靠,可作为左旋四氢巴马汀自微乳的质量控制方法。Objective To establish a content determination method of L- tetrabydropalmatine in L- tetrahydaopalmatine Self- Microemul- sion by HPLC. Methods The column was Pbenomenex Desc Gemini- NX 5 μ C18 column（250 mm ×4. 6 mm, 5 μm, 110A）; the mobile phase consisted of 0. 1% phosphoric acid solution（pH adjusted to 6.32 with triethylamine） and methanol（35 ： 65）; the detection wavelength was set at 280 nm; the injection volume was 10 μL; the flow rate was 1.0 mL/min and the column temperature was 30 ℃. Results The calibration curve was linear in the range of 0.1 to 1.0 g/L（ r =0. 999 9）; RSD of accuracy was 0. 38%, and the RSD of stability was 0.96%.The content of L-tetrahydropalmatine was 91.81% and the RSD was 0. 58% in the repeatability test. The recovery rate of L- tetrahydropalmatine was 99.97% and the RSD was 0.60% （n =9） in the recovery test. Conclusion The method is simple, sensitive, reproducible, accurate and reliable, which can be used as a quality control method for L- tetrahydropalmatine self- microemulsion.

关 键 词：高效液相色谱法 左旋四氢巴马汀自微乳 含量测定 

分 类 号：R927.2[医药卫生—药学] R971.3