高效液相色谱-质谱法同时测定复合维生素B片中5种成分含量  

Simultaneous Determination of Five Components in Compound Vitamin B Tablets by HPLC-MS

作　　者：李姮 李玲 吴琦 陈乃江 LI Heng;LI Ling;WU Qi;CHEN Naijiang(Lianyungang Institute for Food and Drug Control,Lianyungang,Jiangsu,China 222006)

机构地区：[1]江苏省连云港市食品药品检验检测中心,江苏连云港222006

出　　处：《中国药业》2022年第9期87-90,共4页China Pharmaceuticals

摘　　要：目的建立同时测定复合维生素B片中维生素B_(1)、维生素B_(2)、维生素B_(6)、烟酰胺和泛酸钙含量的高效液相色谱-质谱法。方法色谱柱为PhenomenexGeminiC18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%甲酸溶液(50∶50,V/V),流速为0.6 mL/min;电喷雾离子源,正离子模式,锥孔电压为15 V,毛细管电压为0.8 kV,单离子记录(SIR)模式下扫描,维生素B_(1)、维生素B_(2)、维生素B_(6)、烟酰胺和泛酸钙的质荷比(m/z)分别为265,377,170,123,220。结果维生素B_(1)、维生素B_(2)、维生素B_(6)、烟酰胺和泛酸钙的质量浓度分别在0.1402~20.9400μg/mL(r=0.9998,n=8),0.0501~29.9000μg/mL(r=0.9999,n=10),0.0074~1.0980μg/mL(r=0.9994,n=8),0.0660~9.8500μg/mL(r=0.9994,n=7),0.0350~20.9200μg/mL(r=0.9996,n=10)范围内与峰面积线性关系良好;精密度、稳定性、重复性试验的RSD均小于4.0%(n=6);平均加样回收率分别为105.34%,103.35%,103.56%,92.62%,96.49%,RSD分别为3.36%,2.88%,2.55%,2.47%,1.80%(n=6)。结论该方法操作简便、结果准确,可用于同时测定复合维生素B片中5种成分的含量。Objective To establish a high-performance liquid chromatography-mass spectrometry(HPLC-MS)method for the simultaneous determination of vitamin B_(1),vitamin B_(2),vitamin B_(6),nicotinamide and calcium pantothenate in Compound Vitamin B Tablets.Methods The chromatographic column was Phenomenex Gemini C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%formic acid solution(50∶50,V/V),the flow rate was 0.6 mL/min.The ionization method was adopted with electrospray ion source and positive ion mode,the cone voltage was 15 V,the capillary voltage was 0.8 kV,scanning in the single ion recording(SIR)mode.The mass-to-charge ratios(m/z)of vitamin B_(1),vitamin B_(2),vitamin B_(6),nicotinamide and calcium pantothenate were 265,377,170,123 and 220,respectively.Results The linear ranges of vitamin B_(1),vitamin B_(2),vitamin B_(6),nicotinamide and calcium pantothenate were 0.1402-20.9400μg/mL(r=0.9998,n=8),0.0501-29.9000μg/mL(r=0.9999,n=10),0.0074-1.0980μg/mL(r=0.9994,n=8),0.0660-9.8500μg/mL(r=0.9994,n=7),0.0350-20.9200μg/mL(r=0.9996,n=10),respectively.The RSDs of precision,stability and repeatability tests were less than 4.0%(n=6).The average recoveries were 105.34%,103.35%,103.56%,92.62%and 96.49%with RSDs of 3.36%,2.88%,2.55%,2.47%and 1.80%(n=6),respectively.Conclusion The method is simple and accurate,which can be used for the simultaneous determination of the five components in Compound Vitamin B Tablets.

关 键 词：复合维生素B片 高效液相色谱-质谱法 维生素B_(1) 维生素B_(2) 维生素B_(6) 烟酰胺 泛酸钙 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.2