高效液相色谱法测定布洛肾素那敏片中棓丙酯的含量

Determination of Propyl Gallate in Ibuprofen Phenylephrine Hydrochloride and Chlorphenamine Maleate Tablets by High Performance Liquid Chromatography

目的建立布洛肾素那敏片中抗氧剂棓丙酯的高效液相色谱分析方法。方法以乙腈:0.1%磷酸水溶液(V/V,20/80)为提取溶液,建立了HPLC法进行棓丙酯含量检测的方法。测定条件为:用十八烷基硅烷键合硅胶为填充剂;以高氯酸钠溶液为流动相A,乙腈为流动相B,进行梯度洗脱;流速为1.0ml/min;检测波长为272nm;柱温为25℃。结果本方法能在25min内完成目标化合物的分离分析。棓丙酯在0.0050 mg/ml^0.0150 mg/ml浓度范围内线性关系良好且R2为1.0000.棓丙酯在50%~150%浓度范围内,回收率为99.6%,能够满足样品测定的要求。结论该方法简便、准确、可靠,重复性好,可用布洛肾素那敏片中棓丙酯的定量分析和质量控制。

Objective A high performance liquid chromatography（HPLC） method was established for the analysis of propyl gallate in Ibuprofen Phenylephrine Hydrochloride and Chlorphenamine Maleate Tablets. Methods A method for the determination of propyl gallate by HPLC was established by using acetonitrile： 0.1% phosphoric acid aqueous solution（V/V, 20/80） as the extraction solution. The determination conditions were as follows： C18 column（十八烷基硅烷键合硅胶柱）; with sodium perchlorate solution and acetonitrile were used as mobile phase. Gradient elution was performed at the flow rate was 1 m L/min.The detection wavelength was 272 nm. The column temperature was 25 °C. Results The separation and analysis of the target compound were accomplished within 25 min using this method. The propyl gallate standard had a good linear relationship in the range of 0.0050 mg/m L-0.0150 mg/m L with R2=1.0000. The average recoveries（50%-150%） was 99.6%, which can meet the requirements of sample determination. Conclusion The proposed method is fast, accurate, sensitive and repeatable, which is suitable for the quantitative analysis of propyl gallate in Ibuprofen Phenylephrine Hydrochloride and Chlorphenamine Maleate Tablets in quantitative analysis and quality control.