Menon G N, White L B
Department of Analytical Research, Abbott Laboratories, North Chicago, IL 60064.
J Pharm Sci. 1981 Sep;70(9):1083-5. doi: 10.1002/jps.2600700931.
A stability-indicating, high-performance liquid chromatographic method is presented for the simultaneous determination of hydrochlorothiazide and triamterene in two-component capsule formulations. An aliquot of the sample is dissolved in a mixture of acetonitrile and aqueous acetic acid, mixed with m-hydroxacetophenone as an internal standard, and chromatographed on octadecylsilane bonded to microparticulate silica using 80% acetate buffer (pH 5.0, 0.004 M)-15% acetonitrile-5% methanol as the mobile phase. The relative standard deviations are +/- 1.1-1.6% for hydrochlorothiazide and +/- 1.7-2.2% for triamterene for two formulations. Recoveries of the two drugs added to placebos ranged from 98.4 to 101.7%.
建立了一种稳定性指示高效液相色谱法,用于同时测定两组分胶囊制剂中的氢氯噻嗪和氨苯蝶啶。取一份样品溶解于乙腈和醋酸水溶液的混合物中,加入间羟基苯乙酮作为内标,以80%醋酸盐缓冲液(pH 5.0,0.004 M)-15%乙腈-5%甲醇为流动相,在键合于微粒硅胶上的十八烷基硅烷柱上进行色谱分析。两种制剂中氢氯噻嗪的相对标准偏差为±1.1 - 1.6%,氨苯蝶啶为±1.7 - 2.2%。添加到安慰剂中的两种药物的回收率在98.4%至101.7%之间。