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Development of a method for determination of purity in tuberculosis therapeutic DNA vaccine based on ion exchange chromatography
Author(s): 
Pages: 628-631
Year: Issue:  11
Journal: Qilu Pharmaceutical Affairs

Keyword:  结核DNA疫苗离子交换色谱法高效液相色谱法纯度;
Abstract: 目的 建立并验证结核治疗性DNA疫苗纯度的高效液相色谱测定方法.方法 采用TSK gel DNA-NPR(4.6 mm×75 mm,2.5μm)色谱柱,流动相:以20 mmol·L-1三羟甲基氨基甲烷(pH=9)为流动相A,以20 mmol·L-1三羟甲基氨基甲烷-1 mol·L-1氯化钠(pH=9)为流动相B,梯度洗脱,柱温:25℃;流速:0.5 mL·min-1;检测波长:260 nm.结果 质粒DNA在0.5~2.5μg的范围内与峰面积呈良好线性关系,R2=0.9998,该法专属性、精密度和耐用性良好,检测限为0.001 mg·mL-1,供试品在24 h内稳定.结论 该方法符合检测结核治疗性DNA疫苗纯度的要求,适用于该产品的质量控制.
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