ACYW135群脑膜炎球菌多糖疫苗中乳糖含量测定

Content Determination of Lactose in ACYW135 Meningococcal Polysaccharide Vaccine

目的建立高效液相色谱法测定乳糖含量的方法。方法研究了流动相、流速及柱温等因素对试验结果的影响,确定了乳糖检测方法的最佳试验条件:色谱柱为AminexHPX-87H柱(300 mm×7.8 mm,17μm),流动相为乙腈-水(60∶40,V/V),流速1.0 mL·mL^-1,柱温为45℃,进样量10μL。结果试验表明,乳糖浓度在1.25~20.00 mg·mL^-1范围内与色谱峰面积呈线性关系,相关系数为r=1,方法检出限为0.02 mg·mL^-1,定量限为0.0625 mg·mL^-1,相对标准偏差(RSD)为0.78%(n=9)。结论该方法操作简便、准确度高、特异性较好,可用于ACYW135群脑膜炎球菌多糖疫苗中乳糖含量测定。

OBJECTIVE To Determine the content of lactose by High Performance Liquid Chromatography method.METHODS A series of experiment parameters such as mobile phase,flow rate and column temperature were optimized and the optimal conditions were chosen:AminexHPX-87H(300 mm×7.8 mm,17μm)column was used,acetonitrile-water(60∶40,V/V)as mobile phase,1.0 mL·mL^-1 as flow rate,45℃as column temperature and 10μL as sample volume.RESULTS The results show that the concentration of lactose was within the range of 1.25-20.00 mg·mL^-1 and linearly dependent on the peak's area.The relative coefficient was 1.The detection limit was 0.02 mg·mL^-1 and quantitative limit was 0.0625 mg·mL^-1.The relative standard deviation(RSD)was 0.78%(n=9).CONCLUSION This method is easy to operate and has good accuracy and selectivity.Thus,this analytical method is suitable for the content determination of lactose in ACYW135 meningococcal polysaccharide vaccine.