论文部分内容阅读
目的建立反相高效液相色谱(RP-HPLC)法测定盐酸度洛西汀含量及其有关物质。方法色谱柱为美国Diamonsil(250 mm×4.6 mm,5μm)C18反相柱;流动相为乙腈-甲醇-缓冲液=30∶30∶40,流速为1.2 ml/min;检测波长230 nm。结果盐酸度洛西汀浓度在4.8～48.0μg/ml范围内,线性关系良好,标准曲线为A=5 147.5C+4.710 7(r=0.999 8,n=7),定量下限0.5μg/ml。结论 RP-HPLC法具有快速、简便、灵敏度高、重现性好等优点,可以用于盐酸度洛西汀的含量测定及有关物质检查。
Objective To establish a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the determination of duloxetine hydrochloride and its related substances. Methods The chromatographic column was a C18 reversed-phase column with Diamonsil (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-methanol-buffer = 30:30:40, the flow rate was 1.2 ml / min and the detection wavelength was 230 nm. Results The concentration of duloxetine hydrochloride was in the range of 4.8 ~ 48.0μg / ml. The standard curve was A = 5 147.5C + 4.710 7 (r = 0.999 8, n = 7) and the limit of quantitation was 0.5μg / ml. Conclusion RP-HPLC method has the advantages of fast, simple, high sensitivity and good reproducibility. It can be used for the determination of duloxetine hydrochloride and related substances.