RP-HPLC法测定阿西美辛缓释片体内活性代谢物吲哚美辛的血药浓度  

Determination of Active Metabolic Substance Indometacin of Acemetacin Sustained-release Tablets in Human Plasma by RP-HPLC Method

作　　者：李冬梅[1] 张强[2] 王丽茹[2] 

机构地区：[1]中国人民解放军第二五一医院药材科,张家口075000 [2]北京大学药学院,北京100083

出　　处：《药物分析杂志》2001年第4期231-233,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：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:A new RP-HPLC method has been developed to determine the concentration of the active metabolite indometacin of acemetacin in plasma.Methods:After extracted by 1,2-dichloro ethane,the plasma sample was analyzed on a C 18 column,the mobile phase was methanol-0 02 mol·L -1 potassium dihydrogen phosphate solution(71∶29,pH adjusted to 4 2 by phosphoric acid),flow rate was 1 0 mL·min -1 , the detection wavelength was 254 nm,the internal standard was naproxenum(concentration was 10 μg·mL -1 ,diluted by methanol).Results:In the concentration range of 0～1 2 μg·mL -1 ,indometacin had a good linear relationship,the linear equation of indometacin was A =0 012 95+0 502 23 C , r =0 999 1, n =7.The intra-day RSD and inter-day RSD of indometacin were 1 8%～6 5%( n =6),2 4%～5 7%( n =5),respectively,the method recovery rate and extraction recovery rate of indometacin were 97 74%～98 88%,RSD less than 13%( n =5) and 81 97%～84 33%,RSD less than 9%,respectively.Conclusion:The method is accurate,highly sensitive and of good reproducibility.

关 键 词：反相高效液相色谱法 阿西美辛 吲哚美辛 血药浓度 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]