RP-HPLC法测定枇杷止咳软胶囊中吗啡的含量范围

Determination of Morphine in the Pipa Zhike Soft Capsules by RP-HPLC

目的:采用反相高效液相色谱法,建立枇杷止咳软胶囊中吗啡含量的测定方法和含量范围。方法:采用HPLC法,使用Agela C18柱(250mm×4.6mm,5μm)色谱柱,采用乙腈-0.01mol/L C7H15Na O3S与0.02mol/L KH2PO4的等量混合液(用10%磷酸调p H值至2.8)(13∶87)等度洗脱,流速1.0m L/min,在220nm下检测,柱温30℃。结果:RP-HPLC法测得吗啡质量浓度在0.01577~0.4731μg范围内呈良好线性关系(r=0.9999);平均回收率为98.7%(RSD=1.6%)。结论:该方法提取简便、定量准确、结果可靠、重复性好,可以测定独家药品枇杷止咳软胶囊中吗啡的含量。

Objective： Using high performance liquid chromatography（ HPLC） method,to establish the determination methods of loquat cough morphine content in soft capsule and content range. Methods： The separation was performed on an agela C18column（ 250 mm ×4. 6mm,5μm）; The mobile phase consisted of acetonitrile-0. 01mol/L sodium heptanesulfonate solution with 0. 02mol/L potassium dihydrogen phosphate solution mixed（ 1∶ 1）（ with 10% phosphoric acid to p H 2. 8）（ 13∶ 87）,with the flow rate of 1. 0m L/min; UV detection wave length was 220 nm and column temperature was 30℃. Results： The calibration curve was linear over the concentration range of 0. 01577 ~ 0. 4731μg for morphine; The average recovery was 98. 7% with RSD = 1. 6%; Conclusion： This method is simple,accurate and reproducible. It can be used to determine the content of morphine in loquat cough soft capsules.