一测多评法测定混合核苷片中核糖核苷含量

Content Determination of Ribonucleoside in Mixed Nucleoside Tablets by the QAMS

目的建立同时测定混合核苷片中腺嘌呤核苷、胞嘧啶核苷、尿嘧啶核苷、鸟嘌呤核苷含量的一测多评法。方法采用高效液相色谱法,色谱柱为迪马Platisil ODS柱(250 mm×4.6 mm,5μm),流动相为30%甲醇-5%甲醇(梯度洗脱),流速为1.0 mL/min,检测波长为260 nm,柱温为30℃,进样量为20μL。建立胞嘧啶核苷、尿嘧啶核苷、鸟嘌呤核苷与内参物腺嘌呤核苷的相对校正因子,计算含量,并与外标法测定结果进行比较。结果胞嘧啶核苷、尿嘧啶核苷、鸟嘌呤核苷的相对腺嘌呤核苷的校正因子分别为1.84,1.40,1.25;且在不同高效液相色谱系统和色谱柱条件下的重现性均良好(RSD<5.0%);4种组分采用一测多评法与外标法所测得结果一致(RSD<5.0%)。结论所建立的一测多评法操作简便、结果准确,可用于混合核苷片中4种有效成分的质量评价。

Objective To establish a quantitative analysis of multi-components by single marker(QAMS)for simultaneous determination of adenosine,cytidine,uridine and guanosine in Mixed Nucleoside Tablets.Methods The high-performance liquid chromatography(HPLC)method was adopted,the chromatographic column was Diamonsil Platisil ODS column(250 mm×4.6 mm,5μm),the mobile phase was 30%methanol-5%methanol(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 260 nm,the column temperature was 30℃,and the injection volume was 20μL.The relative correction factors(RCFs)of cytidine,uridine and guanosine were established with adenosine as the internal reference.The contents of the above four ribonucleoside components were calculated,and the results were compared with those by the external standard method(ESM).Results The RCFs of cytidine,uridine and guanosine relative to adenosine were 1.84,1.40 and 1.25 respectively,and the reproducibility was good with the different chromatographs and chromatographic columns(RSD<5.0%).The contents determination of the above four ribonucleoside components by the QAMS were consistent with those by the ESM(RSD<5.0%).Conclusion The established QAMS is simple and accurate,which can be used for the quality evaluation of four effective components in Mixed Nucleoside Tablets.