CAJ | 학술논문

　　目的：建立RP-HPLC法测定奥美沙坦酯原料药含量及其有关物质的方法。方法：色谱柱为WelchromC8柱（4.6*150,5um），以乙腈-磷酸缓冲盐溶液为流动相进行梯度洗脱，流速为1.0ml/min，柱温25℃，检测波长256nm。结果：确定了奥美沙坦酯合成中引入的6个杂质以及奥美沙坦酯的峰位置，主峰能与相邻杂质峰较好的分离。杂质含量均小于0.1%。结论：采用反相高效液相色谱方法简准确、快捷，可有效的控制奥美沙坦酯中的有关物质。
　　목적：건립RP-HPLC법측정오미사탄지원료약함량급기유관물질적방법。방법：색보주위WelchromC8주（4.6*150,5um），이을정-린산완충염용액위류동상진행제도세탈，류속위1.0ml/min，주온25℃，검측파장256nm。결과：학정료오미사탄지합성중인입적6개잡질이급오미사탄지적봉위치，주봉능여상린잡질봉교호적분리。잡질함량균소우0.1%。결론：채용반상고효액상색보방법간준학、쾌첩，가유효적공제오미사탄지중적유관물질。
Objective To establish the control method for Olmesartan medoxomil and its related substances with RP-HPLC. Methods:The analysis was conducted on Inertsil WelchromC8 (4.6mm×150mm,5um) with a mo-bile phase of acetonitrile-phosphate buffer by gradient elution at a flow of 1.0ml/min. The column temperature was 25 and the detection wave length was 256nm.Result:The retention times of olmesartan medoxomil and its six relevant impurities are determined ;the separation is good and the purity of the related substances are less than 0.1%. Conclusion:This method is accurate,specific and can be used for the quality control of Olmesartan me-doxomil.