El-Gindy A, Ashour A, Abdel-Fattah L, Shabana M M
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Suez Canal University, Ismailia 41522, Egypt.
J Pharm Biomed Anal. 2001 May;25(2):171-9. doi: 10.1016/s0731-7085(00)00480-5.
Two methods are described for the simultaneous determination of benazepril HCl and hydrochlorothiazide in binary mixture. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 238 and 275 nm for benazepril HCl and hydrochlorothiazide, respectively. The separation was carried out on Merck HPTLC aluminum sheets of silica gel 60 F(254,) using ethyl acetate-methanol-chloroform (10:3:2 v/v) as mobile phase. Second order polynomial equation was used for the regression line in the range 2-20 and 2.5-25 microg/spot for benazepril HCl and hydrochlorothiazide, respectively. The second method was based on HPLC separation of the two drugs on reversed phase, ODS column at ambient temperature using a mobile phase consisting of acetonitrile and water (35:65 v/v) and adjusting to pH 3.3 with acetic acid. Quantitation was achieved with UV detection at 240 nm based on peak area with linear calibration curves at concentration ranges 10-60 and 12.5-75 microg ml(-1) for benazepril HCl and hydrochlorothiazide, respectively. The two proposed methods were successfully applied to the determination of both drugs in laboratory prepared mixtures and in commercial tablets. No chromatographic interference from the tablets excipients was found.
本文描述了两种同时测定二元混合物中盐酸贝那普利和氢氯噻嗪的方法。第一种方法基于用高效薄层色谱法（HPTLC）分离这两种药物，然后分别在238nm和275nm处对盐酸贝那普利和氢氯噻嗪的斑点进行光密度测定。分离在默克硅胶60F(254)高效薄层铝板上进行，以乙酸乙酯-甲醇-氯仿（10:3:2 v/v）为流动相。二阶多项式方程分别用于盐酸贝那普利和氢氯噻嗪在2-20和2.5-25μg/斑点范围内的回归线。第二种方法基于在室温下，在反相ODS柱上用高效液相色谱法（HPLC）分离这两种药物，流动相由乙腈和水（35:65 v/v）组成，并用乙酸调节至pH 3.3。基于峰面积，在240nm处用紫外检测进行定量，盐酸贝那普利和氢氯噻嗪的浓度范围分别为10-60和12.5-75μg ml(-1)时具有线性校准曲线。所提出的两种方法已成功应用于实验室配制混合物和市售片剂中两种药物的测定。未发现片剂辅料产生色谱干扰。
