摘要
建立了超高效液相色谱法检测止咳平喘类制剂中可能添加的14种药物。采用Acquity UPLC BEH Shield RP18色谱柱,以0.25%甲酸铵溶液(用甲酸调至pH 3.2)∶甲醇为流动相,线性梯度洗脱,使用UPLC-DAD检测,检测波长258 nm,结合保留时间和UV光谱定性。结果 14种化合物分离完全,回收率为96.3%~103.4%,RSD为0.08%~0.72%。在16种止咳平喘类制剂中检出了盐酸氨溴索、醋酸泼尼松和咖啡因。该方法准确、快速、灵敏度高,可为止咳平喘类制剂中可能违禁添加化学成分的检测提供参考。
A UPLC-DAD method was established for the determination of fourteen drugs that may be illegally added in anti-cough and antiasthmatic preparations. An Acquity UPLC BEH Shield RP18 column was used, with the mobile phase of 0.25% ammonium formate solution (adjusted to pH 3.2 with formic acid) : methanol by linear gradient elution, at the detection wavelength of 258 nm. The qualitative analysis was carried out based on retention time and spectrum by UPLC-DAD. Under the above conditions, all of the fourteen compounds have a good separation. Their recoveries were 96.3 %-103.4%0, with RSDs of 0.08 %-0.72 %. Ambroxol hydrochloride, prednisone acetate and caffeine were detected in sixteen kinds of anti-cough and antiasthmatic samples. This method is accurate, rapid and sensitive, which could be a reference method for the determination of some drugs that may be illegally added in anti-cough and antiasthmatic preparations.
作者
夏方亮
王玉林
王建强
曹洪杰
邵晓玮
XIA Fangliang;WANG Yulin;WANG Jianqiang;CAO Hongjie;SHAO Xiaowei(Binzhou Food and Drug Inspection and Testing Center, Binzhou 25660)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2018年第5期651-655,共5页
Chinese Journal of Pharmaceuticals
关键词
止咳平喘
违禁添加
超高效液相色谱
含量测定
anti-cough and antiasthmatic
illegally adding
UPLC
content determination