反相高效液相色谱法测定制剂中西尼地平和缬沙坦的含量

Farhana V. Buchiya, H. Raj, V. Jain, Mihirkumar G. Patel, Kaushik P. Patel
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引用次数: 2

摘要

建立了反相高效液相色谱法(RP-HPLC)测定原料药和复方制剂中西尼地平和缬沙坦的含量。该方法快速、准确、精密度高、简便、经济。采用Luna C18 100A◦(250 mm×4.6 mm i.d) 5 μm反相柱(phenomenex, Luna®)梯度分离,流动相为乙腈:水(85:15,v/v)。流速为1.0 ml/min,在240 nm处监测流出物。色谱图显示,西尼地平和缬沙坦的保留时间分别为2.083 min和5.458 min。验证了该方法的系统适用性、线性度、精密度、准确度专一性、坚固性、鲁棒性、LOD和LOQ。西尼地平和缬沙坦的回收率分别为100.36%和100.14%。西尼地平和缬沙坦的定量限分别为0.037、0.31μg/ml和0.206μg/ml、0.62μg/ml。该方法可用于原料药和混合制剂中西尼地平和缬沙坦的定量测定。©2020由创新出版社出版。这是一篇基于CC BY-NC许可的开放获取文章(https://creativecommons.org/licenses/by-nc/4.0/)
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Method development and validation of RP-HPLC for simultaneous estimation of cilnidipine and valsartan in synthetic mixture
Reverse phase-high performance liquid chromatography (RP-HPLC) method have been developed and validated for the estimation of Cilnidipine and Valsartan in bulk drug and synthetic mixture. The developed method is rapid, accurate, precise, simple and economical. The separation was carried out using Luna C18 100A◦ (250 mm×4.6 mm i.d.) 5 μm reverse phase column (phenomenex, luna®) in gradient mode, with mobile phase containing Acetonitrile: Water (85:15, v/v). The flow rate is 1.0 ml/min and effluents are monitored at 240 nm. Chromatogram showed peak at a retention time of 2.083 min for Cilnidipine and 5.458 min for Valsartan. The method is validated for system suitability, linearity, precision, accuracy specificity, ruggedness, robustness, LOD and LOQ. Recovery of Cilnidipine and Valsartan is found to be 100.36% and 100.14% respectively. The LOD and LOQ for estimation of Cilnidipine and Valsartan are found to be 0.037μg/ml, 0.31μg/ml and 0.206μg/ml, 0.62μg/ml respectively. Proposed method can be successfully applied for the quantitative determination of Cilnidipine and Valsartan in bulk drug and in synthetic mixture. © 2020 Published by Innovative Publication. This is an open access article under the CC BY-NC license (https://creativecommons.org/licenses/by-nc/4.0/)
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