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目的:建立复方赖诺普利片(每片含赖诺普利10.0 mg、氢氯噻嗪12.5 mg)溶出度的HPLC测定方法。方法:以0.1mol·L~(-1)盐酸900 ml为溶出介质,转速为50 r·min~(-1),用高效液相色谱法测定,检测波长210 nm。结果:赖诺普利、氢氯噻嗪分别在1.8～37.4μg·ml~(-1)和2.5～49.9μg·ml~(-1)范围内线性关系良好(r=0.999 9),平均回收率分别为100.2%,100.6%;RSD分别为0.67%,0.95%(n=9)。赖诺普利、氢氯噻嗪30 min的累计溶出度分别达80%和70%以上。结论:该法操作简便、准确、可靠,适用于复方赖诺普利片的质量研究。
Objective: To establish an HPLC method for the determination of dissolution of compound lisinopril tablets (each tablet containing lisinopril 10.0 mg, hydrochlorothiazide 12.5 mg). Methods: 900 ml of 0.1 mol·L -1 hydrochloric acid was used as dissolution medium at the speed of 50 r · min -1, and the detection wavelength was 210 nm by high performance liquid chromatography. Results: There was a good linear relationship between lisinopril and hydrochlorothiazide in the range of 1.8 ~ 37.4μg · ml ~ (-1) and 2.5 ~ 49.9μg · ml ~ (-1) (r = 0.999 9) .The average recoveries were 100.2% and 100.6%, respectively; RSD was 0.67% and 0.95% respectively (n = 9). The cumulative dissolution rate of lisinopril and hydrochlorothiazide for 30 min reached 80% and 70%, respectively. Conclusion: The method is simple, accurate and reliable and is suitable for the quality study of compound lisinopril tablets.