| 引用本文: | 杨青军,王华,高延甲,李俊卿,焦建东,权勤波,陈金泉.替代对照品法在镇静安神类药物HPLC快速检验方法中的应用[J].中国现代应用药学,2015,32(11):1376-1381. |
| YANG Qingjun,WANG Hua,GAO Yanjia,LI Junqing,JIAO Jiandong,QUAN Qinbo,CHEN Jinquan.Application of Substitution Method of Reference Substance in the Rapid Determination of Sedative Drugs by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(11):1376-1381. |
|
| 摘要: |
| 目的 采用替代对照品法建立镇静安神类药物氯氮卓、马来酸咪达唑仑、硝西泮、艾司唑仑、奥沙西泮、劳拉西泮和阿普唑仑的高效液相色谱快速检验方法。方法 采用Agilent ZORBAX Eclipse Plus C8色谱柱(4.6 mm×150 mm，5 μm)，流动相：0.01 mol·L-1磷酸二氢钾溶液(pH 2.5)-(甲醇-乙腈1∶1)(57∶43)，流速：1.0 mL·min-1，柱温：30 ℃。采用相对容量因子和紫外光谱相似度双指标进行定性；采用相对校正因子法进行定量分析。结果 在确定的色谱条件下，氯氮?、咪达唑仑、硝西泮、艾司唑仑、奥沙西泮、劳拉西泮和阿普唑仑完全分离；采用紫外光谱相似度和相对容量因子进行定性，结果准确可靠；采用替代对照品法，计算药物的相对校正因子进行含量测定，能有效减少对照品的使用，加快高效液相色谱分析速度。结论 该方法快速、简便、可靠，适用于快速检验镇静安神类药物。 |
| 关键词: 镇静安神类药物 紫外光谱相似度 高效液相色谱法 替代对照品法 快检技术 |
| DOI： |
| 分类号: |
| 基金项目: |
|
| Application of Substitution Method of Reference Substance in the Rapid Determination of Sedative Drugs by HPLC |
|
YANG Qingjun, WANG Hua, GAO Yanjia, LI Junqing, JIAO Jiandong, QUAN Qinbo, CHEN Jinquan
|
|
Dongying Inspection Center for Food and Drug, Dongying 257091, China
|
| Abstract: |
| OBJECTIVE To establish a rapid HPLC method for sedative drugs (chlordiazepoxide，midazolam，nitrazepam，estazolam, oxazepam, lorazepam and alprazolam) by substitution method of reference substance. METHODS The Agilent ZORBAX Eclipse Plus C8 column(4.6 mm×150 mm, 5 μm) was adopted. The mobile phase was 0.01 mol·L-1 potassium didydrogen phosphate(pH 2.5)-(methanol-acetonitrile 1∶1)(57∶43). The flow rate was 1.0 mL·min-1 and the column temperature was 30 ℃. The qualitation was measured by relative retention time and spectral similarity. The relative correction factor for quantification analysis was used for content determination. RESULTS The 7 sedative drugs got complete separation. The qualitation was more accurate by applying the double indicator. The relative correction factor method for quantification which required less reference substances in the on-site screening enabled rapid drug-testing. CONCLUSION This method is rapid, simple and reliable for the rapid determination of sedative drugs. |
| Key words: sedative drugs UV spectra similarity HPLC substitution method of reference substance rapid testing technique |
