麦白霉素片中麦迪霉素A_1的含量测定

Determination of Midecamycin A1 in Meleumyin Tablets by HPLC

用高效液相色谱法测定麦白霉素片中麦迪霉素A含量。方法:色谱柱为C柱;流动相为0.2mol/L甲酸铵(用三乙胺调节118pH值至7.3)-乙腈(62∶38);流速为1.0mL/min;检测波长为232nm;柱温为30℃。结果:麦白霉素片中麦迪霉素A峰与相邻峰的分离1度大于1.5,麦白霉素浓度的线性范围为0.4～4.0mg/mL,r=0.9999,回归方程为A=6408486C+5595,平均回收率为100.4%,RSD=1.0%;方法精密度RSD=0.1%(n=6),日内精密度RSD=0.2%(n=6),日间精密度RSD=0.4%(n=8)。结论:HPLC法简便易行,且具有较好的选择性、准确性和精密度。

Objective:To establish a method of determination of midecamycin A1 in meleumyin tablets.Methods:In the HPLC system,C18 column was used as stationary phase,the mobile phase was 0.2 mol/L ammonium formate solution-acetonitrile(62 ∶38) with a flow rate 1.0 mL/min,the detection wavelength was 232 nm.Results:Resolution of midecamycin A1 was more than 1.5 with neighbour peak.The calibration curve was linear in the range of 0.4～4.0 mg/mL,r=0.999 9.A=6 408 486C+5 595.The average recovery was 100.4%,RSD=1.0%.Conclusion:The method is simple,accurate and may be adopted for quality control of meleumyin tablets.