Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM University, Tamilnadu, Kattankulathur 603 203, India.
J Anal Methods Chem. 2012;2012:108281. doi: 10.1155/2012/108281. Epub 2012 Apr 8.
A Simple high-performance thin layer chromatography (HPTLC) method for separation and quantitative analysis of losartan potassium, amlodipine, and hydrochlorothiazide in bulk and in pharmaceutical formulations has been established and validated. After extraction with methanol, sample and standard solutions were applied to silica gel plates and developed with chloroform : methanol : acetone : formic acid 7.5 : 1.3 : 0.5 : 0.03 (v/v/v/v) as mobile phase. Zones were scanned densitometrically at 254 nm. The R(f) values of amlodipine besylate, hydrochlorothiazide, and losartan potassium were 0.35, 0.57, and 0.74, respectively. Calibration plots were linear in the ranges 500-3000 ng per spot for losartan potassium, amlodipine and hydrochlorothiazide, the correlation coefficients, r, were 0.998, 0.998, and 0.999, respectively. The suitability of this method for quantitative determination of these compounds was by validation in accordance with the requirements of pharmaceutical regulatory standards. The method can be used for routine analysis of these drugs in bulk and in formulation.
建立并验证了一种简单的高效薄层色谱(HPTLC)法,用于分离和定量分析洛沙坦钾、氨氯地平和氢氯噻嗪的原料药和制剂。用甲醇提取后,将样品和标准溶液点样于硅胶板上,以氯仿-甲醇-丙酮-甲酸 7.5:1.3:0.5:0.03(v/v/v/v)为流动相展开。在 254nm 下进行扫描比色。苯磺酸氨氯地平、氢氯噻嗪和洛沙坦钾的 R(f) 值分别为 0.35、0.57 和 0.74。洛沙坦钾、氨氯地平和氢氯噻嗪的点样量在 500-3000ng 范围内呈线性,相关系数 r 分别为 0.998、0.998 和 0.999。该方法符合药物监管标准的要求,可用于这些化合物的定量测定,适用于原料药和制剂的常规分析。