RP-HPLC-UV波长切换法同时测定复方硝酸异山梨酯胶囊中5种成分的含量

Simultaneous Determination of 5 Components in Compound Isosorbide Dinitrate Capsules by RP-HPLCUV Wavelength Switching Method

目的：建立同时测定复方硝酸异山梨酯胶囊中氢氯噻嗪、卡托普利、阿司匹林、硝酸异山梨酯和尼群地平含量的方法。方法：采用反相高效液相色谱。紫外波长切换法。色谱柱为YMC—PackProC。。柱，流动相为乙腈-水（用磷酸调节pH至2．5，进行梯度洗脱），流速为1．0ml／min，柱温为40℃，进样量为5μl，检测波长0～5．6min为271nm，〉5．6～8．0min为215nm，〉8．0～12．0min为276nm，〉12．0～17．0min为303nm，〉17．0～23．0min为230nm，〉23．0～35．0min为235nm。结果：氢氯噻嗪、卡托普利、阿司匹林、硝酸异山梨酯、尼群地平检测质量浓度分别在7．97～510．38、16．09～1030．02、16．42～1050．60、5．10～326．20、8．48～542．60μg／ml范围内与峰面积积分值呈良好的线性关系（r=0．9997、0．9997、0．9995、0．9996、0．9995）；精密度、稳定性、重复性试验的RSD≤1．54％；平均加样回收率分别为99．60％、99．30％、99．61％、98．88％、99．89％，RSD分别为0．77％、0．61％、0．41％、0．74％、0．88％（n=6）。结论：该方法简便、快速、准确、重复性好，可用于复方硝酸异山梨酯胶囊的质量控制。

OBJECTIVE： To establish the method for simultaneous determination of hydrochlorothiazide, captopril, aspirin, isosorbide dinitrate and nitrendipine in Compound isosorbide dinitrate capsules. METHODS： RP-HPLC-UV wavelength switching method was adopted. The separation was carried out on a YMC-Pack Pro-C18 column with acetonitrile （mobile phase A）-water （adjusted pH to 2.5 with phosphpric acid, mobile phase B） in a gradient elution mode at the flow rate of 1.0 ml/min. The column temperature was set at 40 ℃ and injection volume was 5 μL. At 0-5.6 min, the detection wavelength was 271 nm. At 5.6-8.0 min, the detection wavelength was 215 nm. At 8.0-12.0 rain, the detection wavelength was 276 nm. At 12.0-17.0 min, the detection wavelength was 303 nm. At 17.0-23.0 min, the detection wavelength was 230 nm. At 23.0-35.0 min, the detection wavelength was 235 nm. RESULTS： The linear ranges of hydroehlorothiazide, captopril, aspirin, isosorbide dinitrate and nitrendipine were 7.97-510.38 μg/ml （r=0.999 7）, 16.09-1 030.02 μg/ml （r=0.999 7）, 16.42-1 050.60 μg/ml （r=0.999 5）, 5.10-326.20 μg/ml （r=0.999 6） and 8.48-542.60 μg/ml （r=0.999 5）, respectively. RSDs of precision, stability and reproducibility tests were lower than 1.54%. The average recovery rates of them were 101.01% （RSD=0.98% , n=6） , 101.38% （RSD=1.01% , n=6） , 101.39% （RSD= 0.57%, n=6）, 102.88%（RSD=1.11%, n=6）, 101.83%（RSD=0.98%, n=6）. CONCLUSIONS： This method is simple, rapid, accurate and reproducible, which is suitable for the quality control of Compound isosorbide dinitrate capsules.