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《化学分析计量》 2022年第01期
DOI:10.3969/j.issn.1008-6145.2022.01.010
柱前衍生高效液相色谱法测定尼莫地平注射液中的甲醛和乙醛
顾晓风1,杨袁1,郝刚1,唐倩倩2
1.苏州市药品检验检测研究中心,江苏苏州 215104; 2.山东绿叶制药有限公司,山东烟台 264670 
Determination of formaldehyde and acetaldehyde in Nimodipine injectionby HPLC with pre-column derivatization
GU Xiaofeng1, YANG Yuan1 , HAO Gang1, TANG Qianqian2
1. Suzhou Institute for Drug Control, Suzhou 215104, China; 2. Shandong Lyuye Pharmaceutical Co., Ltd., Yantai 264670, China 
摘要:建立柱前衍生高效液相色谱测定尼莫地平注射液中甲醛和乙醛含量的方法。以2,4-二硝基苯肼为衍生建立柱前衍生高效液相色谱测定尼莫地平注射液中甲醛和乙醛含量的方法。以2,4-二硝基苯肼为衍生化试剂,室温反应30 min ,采用高效液相色谱法检测,色谱柱为Waters XBridge C8柱(250 mm×4.6 mm , 5μm),流动相为乙腈-水(体积比为50∶50),等度洗脱,流量为1.0 mL/min ,柱温为30℃,检测波长为360 nm,进样体积为20 μL。甲醛、乙醛的色谱峰面积与质量浓度分别在0.01~1.00μg/mL、0.01~1.20μg/mL范围内线性关系良好,相关系数均为0.999 9,测定结果的相对标准偏差分别为0.86%和1.02%(n=6),平均加标回收率分别为104.3%和92.0%。 
Abstract:A HPLC method was established for the quantitative determination of formaldehyde and acetaldehyde in Nimodipine injection with pre-column derivatization. Formaldehyde and acetaldehyde reacted with 2,4- dinitrophenylhydrazine (DNPH) for 30 min at room temperature. The phenylhydrazone compounds were simultaneously detected by HPLC. The chromatographic column was Waters XBridge C8 column(250 mm×4.6 mm, 5μm), the mobile phase was acetonitrile-water (50∶50), and the flow rate was 1.0 mL/min. The column temperature was 30℃. The detection wavelength was 360 nm. The volume of injection was 20μL. The chromatographic peak area of formaldehyde was linear with the mass concentration in the range of 0.01-1.00μg/mL with the corelation coefficient of 0.999 9, and the chromatographic peak area of acetaldehyde was linear with the mass concentration in the range of 0.01-1.20μg/mL with the corelation coefficient of 0.999 9. The relative standard deviations of the detection results from parallel tests were 0.86% and 1.02% (n=6), and the average recoveries were 104.3% and 92.0%, respectively. 
关键词:尼莫地平注射液;聚乙二醇;甲醛;乙醛;柱前衍生化;高效液相色谱 
Keywords:Nimodipine injection; polyethylene glycol; formaldehyde; acetaldehyde; pre-column derivatization; HPLC22+ 
本文引用格式:
顾晓风,杨袁,郝刚,等.柱前衍生高效液相色谱法测定尼莫地平注射液中的甲醛和乙醛[J].化学分析计量,2022,31(1):41.
GU Xiaofeng,YANG Yuan,HAO Gang,et al. Determination of formaldehyde and acetaldehyde in Nimodipine injection by HPLC with pre-column derivatization[J]. Chemical Analysis and Meterage,2022,31(1):41. 

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