Study of forced degradation behavior of idrocilamide and development of stability indicating LC method

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• 作者：O. M. El-Houssini
• 关键词：idrocilamide ; forced degradation studies ; accelerated oxidation ; stability indicating method
• 刊名：Journal of Analytical Chemistry
• 出版年：2014
• 出版时间：October 2014
• 年：2014
• 卷：69
• 期：10
• 页码：1003-1008
• 全文大小：181 KB
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• 作者单位：O. M. El-Houssini (1)
  
  1. National Organization for Drug Control and Research, Cairo, Egypt 51 Wezaret EL-Zerah st, Agouza, Giza, P.O. box 12553, Egypt
  
• ISSN：1608-3199

文摘

The objective of this study was to report the stability profile of novel muscle relaxant drug idrocilamide (Idr) based on information obtained from forced degradation studies. The drug was subjected to acidic (1 M HCl) and alkaline (1 M NaOH) hydrolysis and oxidative decomposition (50% H2O2). The products formed under different stress conditions were investigated by LC. The LC method was fine tuned using the samples generated from forced degradation studies. Satisfactory resolution between peaks with the shortest possible analysis time was achieved on C18 5 μm column (Luna, Phenomenex, USA), with mobile phase methanol-acetonitrile-water-glacial acetic acid (25: 30: 44: 1, v: v: v: v), pumped at 1 mL/min flow rate. Quantification was achieved at 280 nm based on peak area, using DAD detector. The proposed LC method was utilized to investigate the accelerated oxidative degradation of Idr. Besides, Idr’s degradants were identified using IR and MS, and the possible degradation pathway was outlined. The proposed method was validated, and the forced degradation studies proved the stability indicating power of the method. The method was also applied to analyze commercial samples.