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作 者:谭菊英 刘庄蔚 何虹 蒋洁 杨欣智 吴明珍 朱健萍 邓鸣 TAN Juying;LIU Zhuangwei;HE Hong;JIANG Jie;YANG Xinzhi;WU Mingzhen;ZHU Jianping;DENG Ming(Guangxi Institute for Food and Drug Control,Nanning,Guangxi,China 530021)
机构地区:[1]广西壮族自治区食品药品检验所,广西南宁530021
出 处:《中国药业》2024年第6期74-77,共4页China Pharmaceuticals
基 金:广西壮族自治区药品监督管理局药品安全科研项目[桂药监科自[2022]037号]。
摘 要:目的建立同时测定口服五维赖氨酸葡萄糖中6种成分含量的高效液相色谱法。方法色谱柱为Alltima C_(18)柱(250 mm×4.6 mm,5μm),流动相为5 mmol/L庚烷磺酸钠溶液(用20%磷酸水溶液调pH至2.5)-乙腈(梯度洗脱),流速为1.0 mL/min,检测波长为200 nm(泛酸钙、盐酸赖氨酸),261 nm(烟酰胺、维生素B2、维生素B1),290 nm(维生素B6),柱温为40℃,进样量为20μL。结果泛酸钙、烟酰胺、维生素B6、盐酸赖氨酸、维生素B2、维生素B1质量浓度分别在1.174~23.49μg/mL、4.220~84.40μg/mL、0.5207~10.41μg/mL、20.88~417.7μg/mL、0.4278~8.555μg/mL、1.676~33.52μg/mL范围内与峰面积线性关系良好(r=0.9999);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均加样回收率分别为101.02%,99.78%,100.30%,100.32%,95.61%,99.26%,RSD分别为0.99%,0.60%,0.57%,1.85%,1.69%,0.71%(n=6)。结论该方法简便,结果准确可靠,可用于同时测定口服五维赖氨酸葡萄糖中6种成分的含量。Objective To establish a high-performance liquid chromatography(HPLC)method for simultaneous determination of six components in Oral Five Vitamins,Lysine and Glucose.Methods The chromatographic column was Alltima C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was 5 mmol/L sodium 1-heptanesulfonate solution(adjusted to pH 2.5 with 20%phosphoric acid aqueous solution)-acetonitrile(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths were 200 nm(calcium pantothenate,lysine hydrochloride),261 nm(niacinamide,vitamin B2,vitamin B1)and 290 nm(vitamin B6),the column temperature was 40℃,and the injection volume was 20μL.Results The linear ranges of calcium pantothenate,niacinamide,vitamin B6,lysine hydrochloride,vitamin B2 and vitamin B1 were 1.174-23.49μg/mL,4.220-84.40μg/mL,0.5207-10.41μg/mL,20.88-417.7μg/mL,0.4278-8.555μg/mL,1.676-33.52μg/mL(r=0.9999)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above six components were 101.02%,99.78%,100.30%,100.32%,95.61%,99.26%,with the RSDs of 0.99%,0.60%,0.57%,1.85%,1.69%,0.71%(n=6)respectively.Conclusion This method is simple,accurate and reliable,which can be used to simultaneously determine the contents of six components in Oral Five Vitamins,Lysine and Glucose.
关 键 词:高效液相色谱法 口服五维赖氨酸葡萄糖 泛酸钙 烟酰胺 维生素B6 盐酸赖氨酸 维生素B2 维生素B1 含量测定
分 类 号:R917[医药卫生—药物分析学] R927[医药卫生—药学]
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