测定泰妥拉唑含量的3种方法研究

Comparisons of three assays for quantitative determination of tenatoprazoie

目的:建立测定泰妥拉唑含量的方法。方法:采用银量法、紫外分光光度法和高效液相色谱法分别对泰妥拉唑进行含量测定。结果:银量法平均回收率为99．9％,RSD为0．13％(n=5),方法精密度为O．09％(n=5); HPLC法在泰妥拉唑浓度为5．020～50．20μg·mL-1的范围内,峰面积与浓度线性关系良好(r=0．999 7),精密度为0．20％(n=6),回收率在99．5％～100．0％;UV法在2．0～12μg·mL-1的范围内线性关系良好(r=0．999 9),精密度为0．81％(n=5),回收率在99．4％～100．3％。结论:3种方法均适用于泰妥拉唑的含量测定,且都有较高的准确度和精密度。银量法结果准确,无需对照品;UV法快速、简便;HPLC法专属性好,可测定主药含量,同时还可进行杂质限度检查。

Objective： To assess three assays for the quantity of tenatoprazole. Methods： Argentometric method, UV spectrophotometry and HPLC method were developed to quantify tenatoprazole, respectively. Results： The argentometric method showed an average recovery rate of 99.9% with RSD of 0.13% （n=5） and the precision of 0.09% （n=5） ; the calibrated linear curve of tenatoprazole was in the range of 5.020～50.20μg·mL^-1（r=0.999 7 ） by HPLC, which had the average recovery rate of 99.5%～100.0% and the precision of 0.20% （n = 6） ; the UV analysis provided a calibrated linear curve within 2.0～12μg·mL^-1（r=0.999 9）. The average recovery was 99.4%～100.3% and the precision of 0.81%（n=5）. Conclusion：The accurate argentometric method can waive reference substance. The rapid UV spectrophotometry gave a convenient tool, and the specific HPLC method offered an analytic way in the quantification of the impurities in tenatoprazole.