RP-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Bisoprolol Fumarate in Tablet Dosage Form

Hetal Patel, D. P. Damahe, Sachin B. Narkhede
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引用次数: 1

Abstract

The objective of the recent study was to develop a simple, accurate and precise RPHPLC method with subsequently validate as per ICH guidelines for the determination of Cilnidipine and Bisoprolol Fumarate using mobile phase (mixture of a Phosphate Buffer: Methanol 60:40) as the solvent. The proposed method involves the measurement of Retention time at analytical wavelength 225 nm was selected. The Retention time of Cilnidipine and Bisoprolol Fumarate was found to be 4.053 and 5.730 respectively. The linearity of the proposed method was investigated in the range of 10-30 μg/ml for Cilnidipine and 5-15 μg/ml for Bisoprolol Fumarate respectively. The method was validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less 2 % RSD.
反相高效液相色谱法同时测定西尼地平和富马酸比索洛尔片剂剂型的含量
最近研究的目的是建立一种简单、准确和精确的RPHPLC方法,并根据ICH指南进行验证,该方法使用流动相(磷酸盐缓冲液:甲醇60:40的混合物)作为溶剂测定西尼地平和富马酸比索洛尔。所提出的方法包括在分析波长225 nm处测量保留时间。西尼地平和富马酸比索洛尔的保留时间分别为4.053和5.730。在西尼地平10 ~ 30 μg/ml和富马酸比索洛尔5 ~ 15 μg/ml范围内考察了该方法的线性关系。验证了该方法的线性度、准确度和精密度。日间和日间变化的RSD均小于2%。
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