Wankhede S B, Raka K C, Wadkar S B, Chitlange S S
Department of Pharmaceutical Chemistry, Padmashree Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Sant Tukaram Nagar, Pimpri, Pune-018, India.
Indian J Pharm Sci. 2010 Jan;72(1):136-40. doi: 10.4103/0250-474X.62239.
Two UV-spectrophotometric and one reverse phase high performance liquid chromatography methods have been developed for the simultaneous estimation of amlodipine besilate, losartan potassium and hydrochlorothiazide in tablet dosage form. The first UV spectrophotometric method was a determination using the simultaneous equation method at 236.5, 254 and 271 nm over the concentration range 5-25, 10-50 and 5-25 mug/ml for amlodipine besilate, losartan potassium and hydrochlorothiazide, respectively. The second UV method was a determination using the area under curve method at 231.5-241.5, 249-259 and 266-276 nm over the concentration range of 5-25, 5-25 and 10-50 mug/ml for amlodipine besilate, hydrochlorothiazide and losartan potassium, respectively. In reverse phase high performance liquid chromatography analysis is carried out using 0.025 M phosphate buffer (pH 3.7):acetonitrile (57:43 v/v) as the mobile phase and Kromasil C18 (4.6 mm i.dx250 mm) column as stationery phase with detection wavelength of 232 nm linearity was obtained in the concentration range of 2-14, 20-140 and 5-40 mug/ml for amlodipine besilate, losartan potassium and hydrochlorothiazide, respectively. Both UV-spectrophotometric and reverse phase high performance liquid chromatography methods were statistically validated and can be used for analysis of combined dose tablet formulation containing amlodipine besilate, losartan potassium and hydrochlorothiazide.
已开发出两种紫外分光光度法和一种反相高效液相色谱法,用于同时测定片剂剂型中苯磺酸氨氯地平、氯沙坦钾和氢氯噻嗪的含量。第一种紫外分光光度法是采用联立方程法在236.5、254和271nm处进行测定,苯磺酸氨氯地平、氯沙坦钾和氢氯噻嗪的浓度范围分别为5 - 25、10 - 50和5 - 25μg/ml。第二种紫外方法是采用曲线下面积法在231.5 - 241.5、249 - 259和266 - 276nm处进行测定,苯磺酸氨氯地平、氢氯噻嗪和氯沙坦钾的浓度范围分别为5 - 25、5 - 25和10 - 50μg/ml。在反相高效液相色谱分析中,使用0.025M磷酸盐缓冲液(pH 3.7):乙腈(57:43 v/v)作为流动相,Kromasil C18(4.6mm内径×250mm)柱作为固定相,检测波长为232nm,苯磺酸氨氯地平、氯沙坦钾和氢氯噻嗪的线性范围分别为2 - 14、20 - 140和5 - 40μg/ml。紫外分光光度法和反相高效液相色谱法均经过统计学验证,可用于分析含有苯磺酸氨氯地平、氯沙坦钾和氢氯噻嗪的复方片剂制剂。