HPLC测定奥美沙坦酯氢氯噻嗪片含量和有关物质

目的:建立高效液相色谱法(HPLC)测定奥美沙坦酯氢氯噻嗪片含量和有关物质的测定方法。方法:采用HPLC,色谱柱:C1(84.6mm×250mm,Kromasil);流动相A:0.02mol/L磷酸二氢钠溶液(用磷酸调节pH至3.0),流动相B:甲醇-乙腈(100∶900),梯度洗脱。结果:奥美沙坦酯和氢氯噻嗪均能与其他杂质较好分离;奥美沙坦酯浓度在0.002026~0.04052mg/mL(r=0.999)范围内线性良好,氢氯噻嗪在0.001265~0.02530mg/mL范围内线性良好(r=1.000)。结论:本方法灵敏、准确,可作为奥美沙坦酯氢氯噻嗪片含量和有关物质的测定方法。

Determination of the Content and Related Substances of Olmesartan Medoxomii/Hydrochloroth- iazide Tablets by HPLC

Objective ：To establish a method by HPLC to determine the content and the related substances of olmesartan medoxomil/hydrochlorothiazide tablets. Methods：The HPLC was performed on a C18 column （4.6 mm ×250 mm, Kromasil） with mobile phase A：0.02 % sodium dihydrogen phosphate solution （pH 3.0 adjusted with phosphoric acid） and mobile phase B ：methanol-acetonitrile （100：900）. Gradient elution was conducted. Resuits：Olmesartan medoxomil and hydrochlorothiazide were completely separated from impurities. There was a good linear range from 0.002 026 to 0.040 52 mg/mL （r = 0.999 ） for olmesartan medoxomil and from 0.001 265 to 0.025 30 mg/mL （r =1.000） for hydrochlorothiazide. Conclusion：The method was proved good in sensitivity and accuracy and can be applied to the determination of olmesartan medoxomil/hydrochlorothiazide tablets and its related substances.