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Stability indicating RP-HPLC method for the determination of flubendazole in pharmaceutical dosage forms

机译：稳定性指示RP-HPLC法测定药物剂型中的氟唑的方法

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摘要

This paper presents a stability study of the drug flubendazole (FLUB) - a benzimidazole carbamate derivative with anthelmintic activity. In order to investigate the stability of the drug, FLUB was subjected to stress degradation under different conditions, as recommended by the International Conference on Harmonization (ICH). A validated HPLC-photodiode array detector (DAD) method was established to resolve FLUB from all its degradation products obtained under acidic, basic, neutral, oxidation, photo-degradation, and thermal conditions, and also from its suspension additives. Chromatographic separation was achieved on a ZORBAX Eclipse Plus C18 column in an isocratic mode of elution using a mixture of water : acetonitrile (50 : 50, v/v) as a mobile phase, at a flow rate of 1 mL min(-1), where FLUB was well resolved from all its degradation products at a t(R) of 5.35 min. The thermostated column compartment (TCC) was adjusted to 25 degrees C and the effluent was monitored by a photo-diode array detector at 254 nm, and FLUB was found to be linear in the range of 0.5-10 mu g mL(-1). The method was validated in terms of accuracy, precision, specificity, robustness, and ruggedness, as per USP guidelines. It was successfully applied to quantify FLUB in bulk powder and in pharmaceutical formulations with complete resolution between FLUB and its suspension additives. Statistical analyses between the suggested method and the official HPLC method using student's-t and F-ratio tests reveal that the suggested method is as accurate and precise as the reported one.
机译：本文呈现了药物絮凝唑（FLUB）的稳定性研究 - 具有具有αmintic活性的苯并咪唑氨基甲酸酯衍生物。为了探讨药物的稳定性，根据协调会议（ICH）的建议，在不同条件下，在不同条件下进行压力降解。建立了经过验证的HPLC-光电二极管阵列检测器（DAD）方法以从酸性，碱性，中性，氧化，光降解和热条件下获得的所有退化产物分解FLUB，以及其悬浮添加剂。在使用水的混合物中的Zorbax Eclipse加上C18柱上达到色谱分离，使用水：乙腈（50：50，v / v）作为流动相，流速为1mL min（-1） ，在5.35分钟的所有降解产物中，Flub均得到很好地解决。将恒温柱隔室（TCC）调节至25℃，通过254nm的光电二极管阵列检测器监测流出物，发现FLUB在0.5-10μgmm（-1）的范围内是线性的。根据USP指南，根据准确性，精确，特异性，鲁棒性和坚固性验证该方法。它成功地应用于量化散装粉末和药物制剂中的泡沫状物，在泡沫状物质和其悬浮添加剂之间具有完全分辨率。使用学生-T和F比试验的建议方法与官方HPLC方法之间的统计分析表明，建议的方法与报告的方法一样准确和精确。

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  • 来源
    《RSC Advances》 |2015年第15期|共9页
  • 作者

    Abdelwahab Nada S.; Abdelrahman Maha M.;

  • 作者单位

    Beni Suef Univ Fac Pharm Dept Pharmaceut Analyt Chem Bani Suwayf 62514 Egypt;

    Beni Suef Univ Fac Pharm Dept Pharmaceut Analyt Chem Bani Suwayf 62514 Egypt;

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  • 正文语种 eng
  • 中图分类 化学;
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