引用本文: | 武敏,黄传兵,胡轲,杜尚云,段强军.HPLC同时测定斑蝥酸钠维生素B6注射液中斑蝥酸钠和维生素B6的含量[J].中国现代应用药学,2021,38(20):2560-2563. |
| WU Min,HUANG Chuanbing,HU Ke,DU Shangyun,DUAN Qiangjun.Simultaneous Determination of Disodium Cantharidinate and Vitamin B6 in Disodium Cantharidinate and Vitamin B6 Injection by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(20):2560-2563. |
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HPLC同时测定斑蝥酸钠维生素B6注射液中斑蝥酸钠和维生素B6的含量 |
武敏1, 黄传兵2, 胡轲3, 杜尚云1, 段强军4
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1.宿州市第一人民医院, 安徽 宿州 234000;2.安徽中医药大学第一附属医院, 合肥 230031;3.太和县食品药品检验所, 安徽 太和 236600;4.安徽中医药大学中西医结合学院, 合肥 230012
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摘要: |
目的 建立斑蝥酸钠维生素B6注射液中斑蝥酸钠和维生素B6含量的同时测定方法。方法 采用HPLC,色谱柱为Syncronis C18(250 mm×4.6 mm,5 μm),流动相为0.02 mol·L-1磷酸二氢钾溶液(磷酸调pH值至2.6)-乙腈,梯度洗脱,流速为1.0 mL·min-1,检测波长为193,290 nm,波长切换法,柱温:30℃。结果 斑蝥酸钠回归方程为Y=1.926X+0.010(r=0.999 7),在0.064 6~0.322 8 mg·mL-1内斑蝥酸钠与峰面积的线性关系良好,平均回收率为98.9%,RSD为1.2%(n=9)。维生素B6回归方程为Y=24.153X+0.670(r=0.999 9),在0.535 9~2.679 7 mg·mL-1内维生素B6与峰面积的线性关系良好,平均回收率为100.2%,RSD为1.0%(n=9);仪器精密度、稳定性和重复性试验的RSD均<2.0%。结论 所建立的方法结果准确、重复性好,可用于斑蝥酸钠维生素B6注射液的质量控制。 |
关键词: 斑蝥酸钠维生素B6注射液 斑蝥酸钠 维生素B6 高效液相色谱法 含量测定 |
DOI:10.13748/j.cnki.issn1007-7693.2021.20.014 |
分类号:R917.101 |
基金项目:安徽高校自然科学研究项目(重点项目)(KJ2020A0395,KJ2020A0424) |
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Simultaneous Determination of Disodium Cantharidinate and Vitamin B6 in Disodium Cantharidinate and Vitamin B6 Injection by HPLC |
WU Min1, HUANG Chuanbing2, HU Ke3, DU Shangyun1, DUAN Qiangjun4
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1.Suzhou First people's hospital, Suzhou 234000, China;2.The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei 230031, China;3.Taihe Institute for Food and Drug Control, Taihe 236600, China;4.College of Integrated Chinese and Western Medicine, Anhui University of Traditional Chinese Medicine, Hefei 230012, China
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Abstract: |
OBJECTIVE To establish method for simultaneous determination of disodium cantharidinate and vitamin B6 in Disodium Cantharidinate and Vitamin B6 injection. METHODS HPLC was performed on a Syncronis C18 column(250 mm×4.6 mm, 5 μm) using the gradient 0.02 mol·L-1 potassium phosphate monobasic solution(adjust pH to 2.6 with H3PO4)(A)-acetonitrile(B) at the 1.0 mL·min-1 flow rate as mobile phase. The column temperature was 30℃ and the detection wavelengths were 193 nm and 290 nm(wavelength switching). RESULTS The linear regression equation of disodium cantharidinate was Y=1.926X+0.010(r=0.999 7); the linear range was 0.064 6-0.322 8 mg·mL-1 with the average recovery of 98.9% and the RSD of 1.2%(n=9). The linear regression equation of vitamin B6 was Y=24.153X+0.670(r=0.999 9); the linear range was 0.535 9-2.679 7 mg·mL-1 with the average recovery of 100.2% and the RSD of 1.0%(n=9). The RSD values for the instrument precision, stability and repeatability were all <2.0%. CONCLUSION The established HPLC method appears to be accurate and reproducible, which can be used for the quality control of Disodium Cantharidinate and Vitamin B6 injection. |
Key words: Disodium Cantharidinate and Vitamin B6 injection disodium cantharidinate vitamin B6 HPLC quantitative analysis |