HPLC法测定二十五味阿魏胶囊中非法添加卡托普利、氯氮、盐酸异丙嗪、硝苯地平的含量

摘要

目的：建立二十五味阿魏胶囊中非法添加卡托普利（ KT）、氯氮（ LD）、盐酸异丙嗪（ YB）、硝苯地平（ XB）的高效液相色谱（HPLC）分析方法。方法采用HPLC法，色谱柱为C18柱（4．6 mm ×250 mm，5μm），流动相为乙腈-0．02％磷酸水溶液梯度洗脱，流速为1．0 mL· min-1，检测波长为215 nm，柱温小于40℃。结果 KT、LD、YB和XB的线性范围分别为0．01012～2．47μg（r2＝1），0．01116～1．116μg（r2＝1），0．00993～0．993μg（r2＝0．9999）和0．00981～0．981μg（r＝1）；平均回收率（n＝6）分别为98．70％，97．19％，95．50％，99．41％；相对标准偏差（RSD）分别为2．86％，2．71％，2．48％和1．98％。结论该方法准确性好，重现性好，可作为二十五味阿魏胶囊中非法添加KT、LD、YB和XB的有效分析方法。%Objective To set up a method for determination of captopril ,chlordiazepoxide ,promethazine hydrochlorine ,nifedipine ille-gally mixed into twenty-five ferulic capsules by HPLC.Methods HPLC method was adopted.Inertsil ODS-SP C18 column (4.6 mm × 250 mm,5 μm) was used,with the mobile phase consisting of water containing 0.02% phosphoric acid and acetonitrile in gradient mode.The flow rate was 1.0 mL· min-1 ,detection wavelength was set at UV 215 nm and column temperature was below 40℃.Results The calibration curve showed good linearity for captopril chlordiazepoxide ,promethazine hydrochlorine and nifedipine in the range of 0.0101 2~2.47 μg(r2 =1),0.011 16 ~1.116 μg(r2 =1),0.009 93~0.993 μg(r2 =0.999 9) and 0.009 81~0.981 μg(r2 =1),respectively.The average recovery rates(n=6) were 98.70%,97.19%,95.50%,and 99.41%,respectively.RSD were 2.86%, 2.71%,2.48%,1.98%, respectively.Conclusions The method is accurate and reproducible ,which can be used for the determina-tion of captopril ,chlordiazepoxide ,promethazine hydrochlorine ,nifedipine illegally mixed into twenty-five ferulic capsules .