一种同时测定片剂中富马酸比索洛尔和苯磺酸氨氯地平的高效液相色谱法的建立与验证
Development and validation of a simultaneous HPLC method for estimation of bisoprolol fumarate and amlodipine besylate from tablets.
作者信息
Vora D N, Kadav A A
机构信息
Chemistry Dept, Mithibai college of Arts, Chauhan Institute of Science and A. J. College of Commerce and Economics, Vile Parle (W), Mumbai-400 056, India.
出版信息
Indian J Pharm Sci. 2008 Jul-Aug;70(4):542-6. doi: 10.4103/0250-474X.44616.
Abstract
A fast, robust and stability indicating RP-HPLC method was developed for simultaneous determination of bisoprolol fumarate and amlodipine besylate in tablets. The mobile phase was mixture of 25 mM ammonium acetate adjusted to pH 5.0 and methanol (65: 35) at 0.8 ml/min. The stationary phase was Luna C18-2 column (3 mu, 50x4.6 mm ID). UV detection was performed at 230 nm. Retention time was 1.45 min and 3.91 min for bisoprolol and amlodipine, respectively. Linearity was established in the range of 8-33 mug/ml. Mean recovery was 99.1% and 98.6% for bisoprolol fumarate and amlodipine besylate, respectively.
摘要
建立了一种快速、稳健且具有稳定性指示功能的反相高效液相色谱法，用于同时测定片剂中富马酸比索洛尔和苯磺酸氨氯地平的含量。流动相为pH值调至5.0的25 mM醋酸铵与甲醇的混合物（65:35），流速为0.8 ml/min。固定相为Luna C18-2柱（3μm，50×4.6 mm内径）。在230 nm波长处进行紫外检测。比索洛尔和氨氯地平的保留时间分别为1.45分钟和3.91分钟。线性范围为8-33μg/ml。富马酸比索洛尔和苯磺酸氨氯地平的平均回收率分别为99.1%和98.6%。
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