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

Application of Substitution Method of Reference Substance in the Rapid Determination of Sedative Drugs by HPLC

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

Key words:  sedative drugs  UV spectra similarity  HPLC  substitution method of reference substance  rapid testing technique

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。

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.