Panderi I E, Parissi-Poulou M
Department of Pharmacy, University of Athens, Panepistimiopolis Zografou, Greece.
J Pharm Biomed Anal. 1999 Dec;21(5):1017-24. doi: 10.1016/s0731-7085(99)00195-8.
A micro-bore liquid chromatographic method was developed for the simultaneous determination of benazepril hydrochloride and hydrochlorothiazide in pharmaceutical dosage forms. The use of a BDS C-18 micro-bore analytical column, results in substantial reduction in solvent consumption and increased sensitivity. The mobile phase consisted of a mixture of 0.025 M sodium dihydrogen phosphate (pH 4.8) and acetonitrile (55:45, v/v), pumped at a flow rate of 0.40 ml min(-1). Detection was set at 250 nm using an ultraviolet detector. Calibration graphs are linear (r better than 0.9991, n = 5), in concentration range 5.0-20.0 microg ml(-1) for benazepril hydrochloride and 6.2-25.0 microg ml(-1) for hydrochlorothiazide. The intra- and interday R.S.D. values were <1.25% (n = 5), while the relative percentage error (Er) was <0.9% (n = 5). The detection limits attained according to IUPAC definition were 0.88 and 0.58 microg ml(-1) for benazepril hydrochloride and hydrochlorothiazide, respectively. The method was applied in the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.
建立了一种微径液相色谱法,用于同时测定药物剂型中的盐酸贝那普利和氢氯噻嗪。使用BDS C-18微径分析柱,可大幅减少溶剂消耗并提高灵敏度。流动相由0.025 M磷酸二氢钠(pH 4.8)和乙腈(55:45,v/v)的混合物组成,以0.40 ml min(-1)的流速泵送。使用紫外检测器在250 nm处进行检测。校准曲线呈线性(r优于0.9991,n = 5),盐酸贝那普利的浓度范围为5.0 - 20.0 μg ml(-1),氢氯噻嗪的浓度范围为6.2 - 25.0 μg ml(-1)。日内和日间相对标准偏差(R.S.D.)值<1.25%(n = 5),而相对百分误差(Er)<0.9%(n = 5)。根据国际纯粹与应用化学联合会(IUPAC)定义获得的检测限,盐酸贝那普利和氢氯噻嗪分别为0.88和0.58 μg ml(-1)。该方法应用于市售片剂的质量控制和含量均匀度测试,证明适用于快速可靠的质量控制。