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目的:建立测定氯沙坦钾氢氯噻嗪片中氯沙坦钾、氢氯噻嗪含量的HPLC方法。方法:色谱柱为Zorbax Eclipse XDBC8(200 mm×4.6 mm,5μm),流动相为0.01 mol·L-1磷酸二氢钾溶液(用磷酸调节pH至3.0)-乙腈(70∶30),流速为1.0 ml·min-1,柱温为35℃,检测波长为271 nm,进样量为20μl。结果:氯沙坦钾的质量浓度在39.63~118.89 μg·ml-1(r=0.999 9),氢氯噻嗪的质量浓度在9.47~28.41 μg·ml-1(r=0.999 6)范围内与其峰面积呈良好的线性关系;平均回收率分别为99.4%(RSD=1.0%,n=9),99.8%(RSD=0.9%,n=9)。结论:该方法简便、快速、准确,重复性好,适用于氯沙坦钾氢氯噻嗪片中两组分的含量测定。
Objective: To establish an HPLC method for the determination of losartan potassium and hydrochlorothiazide in losartan potassium hydrochlorothiazide tablets. METHODS: The chromatographic column was Zorbax Eclipse XDBC8 (200 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid) -acetonitrile (70:30) 1.0 ml · min-1, the column temperature was 35 ℃, the detection wavelength was 271 nm, and the injection volume was 20μl. Results: The concentration of losartan potassium in the range of 39.63-118.89 μg · ml-1 (r = 0.999 9) and the peak area of hydrochlorothiazide in the range of 9.47-28.41 μg · ml-1 (r = 0.999 6) The average recoveries were 99.4% (RSD = 1.0%, n = 9) and 99.8% (RSD = 0.9%, n = 9) respectively. Conclusion: The method is simple, rapid, accurate and reproducible. It is suitable for the determination of two components in losartan potassium hydrochlorothiazide tablets.