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    高效液相色谱法同时测定精氨酸布洛芬片剂中布洛芬和精氨酸的含量

    Simultaneous Determination of Ibuprofen and Arginine in Arginine Ibuprofen Tablets by High Performance Liquid Chromatography

    • 摘要: 取精氨酸布洛芬片剂,去除包衣,研磨,用体积比为8∶2的乙腈-水混合液溶解,采用高效液相色谱法(HPLC)测定精氨酸布洛芬片剂中主药布洛芬和关键辅料精氨酸的含量。以Dikma Silversil C18键合硅胶色谱柱(250 mm×4.6 mm,5.0 μm)为固定相,体积比为8∶2的乙腈-水混合液(用磷酸调节水的pH至2.5)为流动相,以光电二极管阵列检测器在230 nm处检测布洛芬,208 nm处检测精氨酸,并以标准曲线法定量分析。结果表明,在优化的色谱条件下,布洛芬与精氨酸可完全分离。布洛芬和精氨酸的质量浓度在一定范围内与对应的峰面积呈线性关系,检出限(3S/N)分别为0.45 mg·L−1和18 mg·L−1。精密度试验中测定值的相对标准偏差(n=6)均小于3.0%,稳定性试验结果显示,混合对照品溶液和样品溶液在室温下放置24 h稳定。布洛芬和精氨酸的加标回收率分别为99.1%~102%和97.4%~102%。

       

      Abstract: Arginine ibuprofen tablets were taken, removed the coating, and ground. The power was dissolved in a mixture of acetonitrile and water at the volume ratio of 8∶2. The main drug ibuprofen and the key excipient arginine in arginine ibuprofen tablets were determined by high performance liquid chromatography (HPLC), using Dikma Silversil C18 bonded silica gel column (250 mm×4.6 mm, 5.0 μm) as the stationary phase, and the mixed solution composed of acetonitrile and water (water adjusted to pH 2.5 with phosphoric acid) at the volume ratio of 8∶2 as the mobile phase. The photodiode array detector was used to detect ibuprofen at 230 nm and arginine at 208 nm, and the standard curve method was used for quantitative analysis. As shown by the results, ibuprofen could be completely separated from arginine under the optimized chromatographic conditions. Linear relationships between the corresponding peak areas and mass concentrations of ibuprofen and arginine were found in definite ranges, with detection limits (3S/N) of 0.45 mg·L−1 and 18 mg·L−1, respectively. RSDs (n=6) of the determined values in the precision test were less than 3.0%. It was shown by the stability test results that the mixed reference solution and sample solution were stable within 24 h at room temperature. And the recoveries were in the ranges of 99.1%-102% for ibuprofen and 97.4%-102% for arginine, respectively.

       

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