高效液相色谱双波长法测定复方罗布麻片Ⅰ中3组分含量  

Content Determination of Three Components in Compound Luobuma Tables Ⅰ by Dual-Wavelengths HPLC

作　　者：刘倩倩 蒋磊 LIU Qianqian;JIANG Lei(Anhui No.2 Provincial People’s Hospital,Hefei,Anhui,China230041)

机构地区：[1]安徽省第二人民医院,安徽合肥230041

出　　处：《中国药业》2021年第11期56-58,共3页China Pharmaceuticals

摘　　要：目的建立测定复方罗布麻片Ⅰ中泛酸钙、氢氯噻嗪及维生素B6含量的高效液相色谱法。方法色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为0.12%庚烷磺酸钠(A,冰醋酸调pH至3.0)-乙腈(B),梯度洗脱,流速为1.0 m L/min,柱温为35℃,检测波长为200 nm(泛酸钙)和275 nm(其他),进样量为20μL。结果泛酸钙质量浓度在1.333~13.350μg/m L(r=0.999 9),氢氯噻嗪质量浓度在7.827~78.270μg/m L(r=1.000 0),维生素B6质量浓度在2.546~25.460μg/m L(r=1.000 0)范围内与峰面积线性关系良好;泛酸钙、氢氯噻嗪、维生素B6的加样回收率分别为100.85%,99.67%,100.74%,RSD分别为1.31%,0.44%,1.36%(n=6)。结论该方法操作简便、重复性好、结果准确,可用于复方罗布麻片Ⅰ的质量控制。Objective To establish a high-performance liquid chromatography( HPLC) method for content determination of calcium pantothenate,hydrochlorothiazide and pyridoxine hydrochloride in Compound Luobuma Tables Ⅰ. Methods The chromatographic column was Kromasil C18 column( 250 mm × 4. 6 mm,5 μm),the mobile phase was 0. 12% heptane sulfonate acid sodium( A,pH was adjusted to 3. 0 with glacial acetic acid)-acetonitrile( B) with gradient elution,the flow rate was 1. 0 m L/min,the column temperature was 35 ℃,the detection wavelengths were 200 nm( calcium pantothenate) and 275 nm( others),and the injection volume was 20 μL. Results The linear ranges of calcium pantothenate,hydrochlorothiazide and pyridoxine hydrochloride were 1. 335-13. 350 μg/m L( r = 0. 999 9),7. 827-78. 270 μg/m L( r = 1. 000 0) and 2. 546-25. 460 μg/m L( r = 1. 000 0),respectively. The recoveries of calcium pantothenate,hydrochlorothiazide and pyridoxine hydrochloride were 100. 85%( RSD = 1. 31%,n = 6),99. 67%( RSD = 0. 44%,n = 6),100. 74%( RSD = 1. 36%,n = 6),respectively. Conclusion The method is simple,repeatable and accurate,which can be used for the quality control of Compound Luobuma Tables Ⅰ.

关 键 词：高效液相色谱法 双波长 复方罗布麻片Ⅰ 泛酸钙 氢氯噻嗪 维生素B6 含量测定 

分 类 号：R927.2[医药卫生—药学] R972.4