HPLC测定替硝唑结肠定位肠溶片含量和有关物质检查

HPLC Determination of Related Substances and Content of Tinidazole Colon Targeting Tablets

目的:建立高效液相色谱法测定替硝唑结肠定位肠溶片中替硝唑含量和有关物质含量。方法:采用ODS柱(4.6 mm×25 cm,10μm),流动相甲醇-水(20:80),流速0.9 mL·min-1,检测波长317 nm,进样量20μL。结果:回归方程为Y=3.987×106X+9.441×104(r=0.9999),线性范围0.025-0.4 mg·mL-1。含量测定回收率为(100.7±0.22)%,(101.8±0.20)%,(101.0±0.05)%。最小检测量为2 ng。结论:此法可用于替硝唑结肠定位肠溶片的有关物质检查和含量测定。

Objective: An HPLC method was established for the determination of related substances and content of tinidazole colon targeting tablets. Methods:Tinidazole(TNZ) was separated on an ODS column(4. 6 mm×25 cm, 10μm)with the mobile phase methanol and water(20: 80) , a flow rate of 0. 9 mL ·min-1 ,and detected at 317 nm. Results:The linear equation wasY = 3. 987×106X + 9. 441×104 ( r = 0. 9999). The range was 0. 025 - 0. 4 mg · mL-1 ,and the recoveries were(100.7±0.22)% , (101. 8±0.20)% , (101.0±0.05)%. Its detection limit was 2 ng. Conclusion:The proposed method is proved to be simple,rapid,reliable and reproducible.