HPLC法测定盐酸仑氨西林的含量及有关物质

Determination of lenampicillin hydrochloride and related substances by HPLC

目的 采用高效液相色谱法测定盐酸仑氨西林含量及有关物质。方法 ODS- C1 8柱 (2 5 0 mm×4 .6 mm,5 μm) ,流动相为 0 .0 78mol/ L 磷酸二氢钾溶液 -乙腈 (75∶ 2 5 ) ,流速 1.0 ml/ min,柱温 4 0℃ ,检测波长2 30 nm。结果 盐酸仑氨西林在 0 .10～ 0 .4 0 mg/ ml的浓度范围内呈良好的线性关系 ,回归方程为 Y=1392 0 5 X- 15 5 1.5 (r=0 .9997) ,最低检测浓度为 0 .6 2 5 μg/ ml,平均回收率为 99.74 % (n=9) ,RSD=0 .2 4 %。结论 本方法简便、快速 ,结果准确、可靠、重现性好。

Objective To establish HPLC method for the determination of lenampicillin hydrochloride and related substances. Methods ODS-C 18 column (250mm×4.6mm, 5μm), 0.078mol/L potassium dihydrogen (KH 2PO 4) solution-acetonitrile (75∶25) as the mobile phase. The flow rate 1.0ml/min. The column temperature was 40℃, detection wavelength was UV 230nm. Results The calibration curves was linear in the concentration range of 0.10～0.40mg/ml, and the regression equation was Y=139205X-1551.5 (r=0.9997). The average recovery rate was 99.74%, RSD=0.24% (n=9, r=0.9997), the detection limit was 0.625μg/ml. Conclusion The method is simple, rapid, reproducible.