【摘要】 通过优化色谱条件，建立专属性良好的高效液相色谱测定多种布洛芬药物制剂中布洛芬含量。采用Dikma Silversil C18键合硅胶色谱柱（250 mm×4.6 mm,5μm）为分析柱，柱温为30℃，以乙腈-磷酸溶液（体积比为80∶20）作为流动相，流量为1.0 mL/min，进样体积为10μL，以光电二极管阵列检测器检测，检测波长为263 nm。采用色谱峰面积外标法测定布洛芬缓释胶囊、原料药和颗粒剂中布洛芬的含量。布洛芬质量浓度在0.091 6～1.099mg/mL范围内与色谱峰面积线性关系良好，相关系数为0.999 7，检出限为3.68μg/mL。布洛芬缓释胶囊、原料药和颗粒剂的样品加标平均回收率分别为99.73%～102.00%、99.45%和101.80%，测定结果的相对标准偏差分别为0.27%～1.18%、1.97%和1.99%(n=6)。优化后的高效液相色谱法准确可靠，适用于多种布洛芬药物制剂中布洛芬的含量测定，可以为多种布洛芬药物制剂的质量评价和质量控制提供参考和方法选择依据。更多还原

【Abstract】 By optimizing the chromatographic conditions, a high performance liquid chromatography(HPLC)method with good specificity was proposed for the content determination of ibuprofen in various ibuprofen pharmaceutical preparations. Dikma Silversil C18 bonded silica gel column(250 mm×4.6 mm, 5 μm) was used as the analytical column, and the column temperature was 30 ℃, acetonitrile-phosphoric acid solution(volume ratio: 80: 20) was used as the mobile phase with the flow rate of 1.0 mL/min, the injection volume was 10 μL. The detection wavelength was set at 263 nm to detect ibuprofen by the photodiode array detector. The content of ibuprofen in ibuprofen sustained-release capsules, drug substances and granules was determined using the chromatographic peak area external standard method. The mass concentration values of ibuprofen had a good linear relationship with the chromatographic peak area in the range of 0.091 6-1.099 mg/mL, and the correlation cofficient was 0.999 7. The detection limit was 3.68 μg/mL. The average recoveries of sample spiking for ibuprofen sustained-release capsules, drug substances and granules were 99.73%-102.00%,99.45% and 101.80%, the relative standard deviations of the determination results were 0.27%-1.18%, 1.97% and 1.99%(n=6),respectively. The optimized method is accurate and reliable, which is suitable for the content determination of ibuprofen in various ibuprofen pharmaceutical preparations, which can provide reference and method selection basis for the quality evaluation and quality control of various ibuprofen pharmaceutical preparations.更多还原