摘要
建立注射用盐酸多柔比星含量及其有关物质的测定方法。采用HPLC法 ,以ShimPackCLC ODS(4 .6×15 0mmID ,5 μm)为色谱柱 ,以含 0 .0 1mol/L十二烷基硫酸钠和 0 .0 2mol/L磷酸 乙腈 (1:1)为流动相 ,以 2 5 4nm为检测波长 ,进行含量测定及有关物质的检测。结果显示 ,线性范围为 0 .0 374～ 1.4939mg/ml,回归方程为 y =2 5 82 5 75 9.7x + 10 12 0 0 .3 ,r =0 .9999,平均回收率为 10 1.3 % (RSD =0 .5 % ,n =9) ,最低检测限 0 .0 2ng/ml,日间日内误差均小于 0 .5 %。提示 ,本法专属性好 ,准确 ,灵敏 ,简便 。
A method for quantitative determination of doxorubicin hydrochloride for injection and its related substances was established, where RP HPLC on the condition as follows,column: Shim pack C 18 (4.6×150mm ID,5μm); mobile phase: a solution containing 0.01mol/L of sodium laurylsulphate and 0.02 mol/L of phosphoric acid acetonitrile (1:1); detective wavelength : 254nm,was applied. Results showed that the standard curve of doxorubicin hydrochloride was linear in the range of 0.00374～1.4939 mg/ml, the regression equation was y =25825759.7 x +101200.3, r =0.9999, the average recovery was 101.3% ( RSD=0.5%, n =9), the lowest detection limit was 0.02ng/ml and the RSD for the intra day and inter day were all less than 0.5%. It was indicated that the method is specific , accurate and sensitive for determinations of doxorubicin hydrochloride for injection and its related substances.
出处
《药学进展》
CAS
2000年第6期355-358,共4页
Progress in Pharmaceutical Sciences
