HPLC法测定奈拉滨注射液的含量

目的: 建立奈拉滨注射液含量及有关物质的HPLC检测方法。 方法: 采用十八烷基硅烷键合硅胶色谱柱,流动相为0.01 mol·L^-1磷酸氢二钠溶液-乙腈(95∶ 5),流速1.0 mL·min^-1,检测波长为249 nm。 结果: 奈拉滨与其相邻杂质峰能完全分离,奈拉滨在0.415~4.155 μg·mL^-1浓度范围内线性关系良好(r=0.9999),高、中、低3种不同浓度的回收率分别为99.8%,99.9%,100%。 结论: 本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。

Objective: To establish an HPLC method for the determination of assay related substances of nelarabine. Methods: The C₁₈column was adopted with the mobile phase of 0.01 mol·L^-1sodium phosphate-acetonotrile (95∶ 5) at the flow rate of 1.0 mL·min^-1and the detection wavelength was 249 nm. Results: The date showed that this method ccould clearly seperate nelarabine peak from its nearby impurity peaks,with a better linear range of 0.415-4.155 μg·mL^-1(r=0.9999),and the average recoveries of its high,middle and low concentrations were 99.8%,99.9% and 100%,respectively. Conclusions: This method is simple accurate and reliable,so it can be used for quality control of its preparation.