HPLC测定奥美沙坦酯氢氯噻嗪片含量和有关物质

Determination of the Content and Related Substances of Olmesartan Medoxomil/Hydrochlorothiazide Tablets by HPLC

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：C18（4．6mm×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：奥关沙坦酯和氢氯噻嗪均能与其他杂质较好分离；奥关沙坦酯浓度在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，可作为奥关沙坦酯氢氯噻嗪片含量和有关物质的测定方法。

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.