HPLC-DAD法同时测定苦碟子注射液中10种核苷类成分

Simultaneous determination of ten nucleoside components in Kudiezi Injection by HPLC-DAD

目的 建立同时测定苦碟子注射液中10种核苷类成分（胞嘧啶、尿嘧啶、胞苷、鸟嘌呤、尿苷、胸腺嘧啶、腺嘌呤、鸟苷、胸苷、腺苷）量的HPLC-DAD方法。方法 采用Diamonsil C18（2）色谱柱（200 mm×4.6 mm，5 μm），流动相为乙腈-水，梯度洗脱。体积流量1.0 mL/min，柱温35 ℃，检测波长260 nm，进样量10 μL。结果 10种核苷类成分线性关系、精密度、稳定性、重复性均符合方法学测定要求，加样回收率为98.63%～102.92%。应用所建立的方法测定了18批苦碟子注射液中10种核苷类成分的量。结论 所建立的用于同时测定苦碟子注射液中核苷类成分的分析方法简单、重复性好、准确可靠，可为苦碟子注射液质量控制提供依据。

Objective To develop a high performance liquid chromatography coupled with a photodiode array detector （HPLC-DAD） method for the simultaneous determination of ten nucleoside components （cytosine, uracil, cytidine, guanine, uridine, thymine, adenine, guanosine, thymidine, and adenosine） in Kudiezi Injection （KI）. Methods The analyses were performed on a Diamonsil C18 （2） column （200 mm × 4.6 mm, 5 μm） eluted with water and acetonitrile in gradient mode. The flow rate was 1.0 mL/min, the detection wavelength was 260 nm, the column temperature was set at 35 ℃, and the injection volume was 10 μL. Results Ten nucleoside compounds have good linear relationship, precision, stability, and repeatability according to the requirements of the methodology determination. The recoveries were 98.63%-102.9%. Ten nucleoside components in eighteen batches of KI were determined by HPLC-DAD method. Conclusion The developed HPLC-DAD method is simple, sensitive, and accurate, and has good repeatability. The ten nucleoside components in KI could be rapidly and accurately quantified by HPLC-DAD. This work provides helpful information for the comprehensive quality evaluation of KI.