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机构地区:[1]皖北煤电集团总医院药剂科,安徽宿州234011 [2]安徽省淮北市食品药品检验所,安徽淮北235000
出 处:《安徽医药》2012年第9期1259-1261,共3页Anhui Medical and Pharmaceutical Journal
摘 要:目的建立感冒灵胶囊的质量标准。方法采用C18色谱柱,流动相为乙腈-0.03 mol·L-1磷酸氢二铵(磷酸调pH至3.1)(12∶88),进样量10μl,柱温为20℃,检测波长214 nm,流速为1.0 ml·min-1。结果对乙酰氨基酚、咖啡因、马来酸氯苯那敏分别在101.17~2 023.40、2.00~40.09和2.05~40.93 mg·L-1范围内线性关系良好,精密度RSD分别为0.05%、0.09%0、.17%(n=8),平均回收率分别为100.4%、99.6%、99.6%。结论结果准确,方法重复性好,可作为该制剂的质量控制指标。Objective To establish a quality standard of ganmaoling capsule. Methods The chromatographic conditions included C 18 chromatographic column and the mobile phase consisted of methyl cyanides-0.03 mol . L - 1 ammonium phosphate dibasic ( pH was adjusted to 2.6 with phosphoric acid) ( 12:88 )with the flow rate of 1.0 ml . min-1. The injection volume was 10 ul and the column temperature was at 20℃. The detection wavelength was 214 nm. Results The calibration curve of paracetamol, caffeine, chlorphenamine maleate were in good linear correlation at the range of 101.17 - 2 023.40,2.00 - 40.09 and 2.05 - 40.93 mg . L - 1, respectively. The average recovery were 100.4% with RSD 0.05% (n = 8) ,99.6% with RSD 0.09% (n = 8 ) ,99.6% with RSD 0. 17% (n = 8), respectively. Conclusion The result is accurate. The method has good reproducibility ,which can be used to control the quality of this preparation.
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