高效液相色谱法测定塞克硝唑片溶出度研究  

HPLC determinion for dissolution test of Secnidazole tablets

作　　者：童达 邱婧 郑金凤 

机构地区：[1]湖南省食品药品检验研究院,长沙410001

出　　处：《中南药学》2015年第6期628-630,共3页Central South Pharmacy

摘　　要：目的建立以高效液相色谱法测定塞克硝唑片溶出度的试验方法,并对4个企业的8批样品进行溶出度测定。方法以0.1 mol·L^-1 HCl 1000 mL为溶出介质,转速50 r·min^-1,溶出取样点为30 min;采用高效液相色谱法测定含量,色谱柱为Ecosil C18（5μm,250 m×0.46 mm）,流动相为甲醇-水（20：80）,检测波长为318 nm,进样量为20μL。结果塞克硝唑在3.117-311.7μg·mL^-1质量浓度与峰面积线性关系良好（r2=0.999）,低、中、高浓度的平均回收率分别为99.5%（RSD为0.5%）、100.0%（RSD为0.8%）、99.8%（RSD为0.7%）（n=3）;8批样品30 min时溶出量的数据为56%-104%。结论各厂家样品溶出度结果差异较大,本方法精密度好,专属性强,重复性好,回收率高,具有区别塞克硝唑片不同处方和生产工艺的能力,能有效控制该制剂的质量。Objective To establish an HPLC method to determine the dissolution of Secnidazole tablets, and to determine the dissolution of 8 batches of samples from 4 factories. Methods HCl（0.1 mol·L^- 1） 1000 mL was used as the medium, the rotation speed 50 r·min^- 1, and the dissolution time was 30 min. HPLC was adopted, and the detection wavelength was 318 nm. The determination was performed on Ecosil C18（5 μm, 250 m×0.46 mm） column with the mobile phase consisting of methanol-water（20 ：80） with the sample size 20 μL. Results A good linearity was obtained between the peak areas and the concentrations of Secnidazole from 3.117 to 311.7 μg·mL^-1（r2=0.999）. The average recovery of low, medium and high concentration was 99.5%（n = 3, RSD = 0.5%）, 100.0%（n = 3, RSD= 0.8%）, and 99.8%（n = 3, RSD = 0.7%） respectively. The dissolution of the 8 batches of samples was 56%-104% within 30 min. Conclusion The dissolution of samples from different manufacturers is greatly different. The method is accurate, reliable and reproducible. It can identify different formulations and production processes, and can be used to control the quality of Secnidazole tablets.

关 键 词：塞克硝唑片 溶出度 高效液相色谱法 

分 类 号：R94[医药卫生—药剂学] R917[医药卫生—药学]