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目的 :建立一种新的RP -HPLC法测定阿西美辛缓释片活性代谢物吲哚美辛的血药浓度。方法 :提取溶剂为 1,2 -二氯乙烷。色谱条件 :C18反相柱 ,流动相为 0 0 2mol·L-1磷酸二氢钾溶液 -甲醇 (71∶2 9,用磷酸调至pH为 4 2 ) ,流速 :1 0mL·min-1,检测波长 :2 5 4nm ,内标为 10 μg·mL-1的萘普生甲醇溶液。结果 :检测浓度在 0～ 1 2 μg·mL-1范围内阿西美辛体内的活性代谢物吲哚美辛的峰面积与浓度有良好的线性关系 ,回归方程 :A =0 0 12 95 + 0 5 0 2 2 3C ,r =0 9991(n =7) ,日内RSD为 1 8%～ 6 5 % (n =6 ) ,日间RSD为 2 4%～ 5 7% (n =5 ) ,平均方法回收率为 97 74%～ 98 88% ,RSD <13 % (n =5 ) ,平均提取回收率为 81 97%～ 84 33% ,RSD <9% (n =5 )。结论 :本法结果准确 ,灵敏度高 ,重现性好。
Objective: To establish a new RP-HPLC method for the determination of the concentration of indometacin, the active metabolite of Simitaxin extended release tablets. Methods: The extraction solvent was 1,2 - dichloroethane. Chromatographic conditions: C18 reverse phase column with a mobile phase of 0 0 2mol·L-1 potassium dihydrogen phosphate-methanol (71: 29, adjusted to pH 4 2 with phosphoric acid) at a flow rate of 10 mL · min -1, Detection of the wavelength: 254nm, internal standard of 10μg · mL-1 naproxen methanol solution. Results: There was a good linear relationship between the peak area of indomethacin and the concentration of active metabolite in the range of 0 ~ 12 μg · mL-1 in Acehimine. Regression equation: A = 0 0 12 95 + The intraday RSD ranged from 18% to 65% (n = 6) and the intraday RSD ranged from 24% to 57% (n = 5) The average recovery was 97 74% -98 88% with RSD <13% (n = 5). The average recovery was 81 97% -84 33% with RSD <9% (n = 5). Conclusion: This method is accurate, sensitive and reproducible.