HPLC法测定罗氟司特含量的研究

Study on HPLC method for determining roflumilast content

目的 建立一种高效液相色谱（HPLC）法测定罗氟司特片的含量。方法 采用HPLC法,色谱柱为Inertsil ODS-3（4.6 mm×250.0 mm,5μm）,以0.01 mol/L甲酸铵缓冲液（p H 4.0）-乙腈（50∶50）作为流动相,检测波长为215 nm,流速为1.5 m L/min,柱温为25℃,测定罗氟司特的含量。结果 罗氟司特浓度在7.496~44.973μg/m L时线性关系良好,回归方程Y=76.76X-4.53,相关系数（r）=1.000 00（n=6）;高、中、低3种浓度平均回收率为99.91%,相对标准偏差（RSD）为0.11%（n=3）,中间精密度试验的RSD为0.12%（n=6）。结论 建立的HPLC法简便、灵敏,结果准确,重复性和耐用性良好,可作为罗氟司特片含量的检验方法。

Objective To establish a HPLC method for the content determination of roflumilast tablets. Methods The high-performance liquid chromatography （HPLC） method was adopted with the Inertsil ODS-3 （4.6 mm×250.0 mm, 5μm） as the chromatographic column. 0.01 mol/L ammonium formate buffer solution （adjusting pH to 4.0）-acetonitrile （50：50） served as the mobile phase, the roflumilast content was detected at the detection wavelength of 215 nm, the flow rate of 1.5 mL/min and the col- umn temperature of 25 ~C. Results The roflumilast concentration in the range of 7.496-44.973 ~g/mL had a good linear relation- ship, the regression equation was Y=76.76X-4.53, r=1.000 00 （n=6）, the average recovery rate of high, middle and low concen- trations was 99.91%,RSD=0.11%（n=3） ;RSD in the intermediate precision test was.0.12%（n=6）. Conclusion The established HPLC method is simple, sensitive and accurate in detection results with good reproducibility and durability, which is suitable for the content determination method of roflumilast tablets.