First order derivative spectrophotometric method for the determination of benidipine hydrochloride pharmaceutical preparations and forced degradation study

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• 作者：Ay?a Karasaka
• 刊名：Optics and Spectroscopy
• 出版年：2015
• 出版时间：June 2015
• 年：2015
• 卷：118
• 期：6
• 页码：1002-1006
• 全文大小：416 KB
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• 作者单位：Ay?a Karasaka (1)
  
  1. Department of Chemistry, Faculty of Science and Letters, Namik Kemal University, Tekirdag, Turkey
  
• 刊物类别：Physics and Astronomy
• 刊物主题：Physics
  Optical Spectroscopy and Ultrafast Optics
  Russian Library of Science
• 出版者：MAIK Nauka/Interperiodica distributed exclusively by Springer Science+Business Media LLC.
• ISSN：1562-6911

文摘

A simple and rapid first order derivative spectrophotometric method was developed for the determination of benidipine hydrochloride in pure form and pharmaceutical preparations. For the first derivative spectrophotometric method, the distances between two extremum values l (peak-to-peak amplitudes), 230.2/241.5 nm. The proposed method was validated according to the ICH guidelines with respect to linearity, limit of detection, limit of quantification, accuracy, precision (intra- and inter-day) and recovery were evaluated. The linearity of the method was in the range of 0.2-.0 μg/mL. Limits of detection and quantification were 0.58 and 1.73 μg/mL, respectively. The proposed method was successfully applied to the analysis of pharmaceutical preparations. In addition, forced degradation studies were performed on the benidipine hydrochloride drag substance. The drug substance was exposed to the stress conditions of hydrolysis (acid and base).