论文部分内容阅读
目的:建立高效液相色谱-紫外检测(HPLC-UV)法测定雷诺嗪缓释片的含量。方法:样品经流动相超声提取后,采用Diamonsil TM C18(250 mm×4.6 mm,5μm)分析柱,甲醇-含醋酸铵20 mmol.L-1和醋酸10 mmol.L-1的水溶液(60∶40)为流动相,检测波长为272 nm。结果:雷诺嗪在20.90～62.70μg.mL-1范围内线性关系良好,平均提取回收率为100.0%,批内精密度RSD小于1.0%。结论:所建立的方法操作简便,准确,适合雷诺嗪制剂的含量测定。
Objective: To establish a method for the determination of ranolazine sustained-release tablets by HPLC-UV. Methods: After the mobile phase was ultrasonic extracted, the samples were separated on a Diamonsil TM C18 (250 mm × 4.6 mm, 5 μm) column with methanol-containing 20 mmol·L-1 ammonium acetate and 10 mmol·L-1 acetate 40) as the mobile phase, the detection wavelength is 272 nm. Results: Ranolazine showed a good linearity in the range of 20.90 ~ 62.70μg.mL-1 with an average recovery of 100.0%. The intra-assay precision RSD was less than 1.0%. Conclusion: The established method is simple, accurate and suitable for the determination of ranolazine.