G. Patel, Sanjay Patel, Dharmesh Prajapati, R. Mehta, South Jordan
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引用次数: 17
摘要
建立了反相高效液相色谱法(RP-HPLC)同时测定苯磺酸氨氯地平和氢氯噻嗪复方剂型的含量。苯磺酸氨氯地平(AML)是一种长效钙通道阻滞剂,用于治疗CVS疾病。氢氯噻嗪(HCT)是一种利尿剂和降压药。流动相为水:甲醇(70:30)。联合剂型检测在245nm下进行,流速0.5ml/min。苯磺酸氨氯地平和氢氯噻嗪的保留时间分别为6.95和2.65 min。苯磺酸氨氯地平6 ~ 18μg/ml和氢氯噻嗪6 ~ 18μg/ml浓度范围内呈线性关系,相关系数分别为0.997和0.9974。探测器由光电二极管阵列探测器组成;反相色谱柱为rp - c18 (5 μm尺寸,250mm, 4.6mm直径)。根据ICH指南对所建立的方法进行验证,发现准确度、精密度等统计分析值符合规定值。该方法具有准确、选择性和快速的特点,可用于常规分析中苯磺酸氨氯地平和氢氯噻嗪的同时测定。关键词:同步估计;氨氯地平Besylate;氢氯噻嗪;高效液相色谱法。DOI: 10.3329/sjps.v3i1.6798 S. J. Pharm。科学通报3(1):49-53
RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Forms
A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C 18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis. Key Words: Simultaneous Estimation; Amlodipine Besylate; Hydrochlorothiazide; HPLC. DOI: 10.3329/sjps.v3i1.6798 S. J. Pharm. Sci. 3(1): 49-53