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首页> 外文期刊>Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry >Forced degradation study on dronedarone and application of validated stability-indicating HPLC-UV method in stability testing of dronedarone tablets
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Forced degradation study on dronedarone and application of validated stability-indicating HPLC-UV method in stability testing of dronedarone tablets

机译：决奈达隆的强制降解研究及已验证的稳定性指示HPLC-UV方法在决奈达隆片的稳定性测试中的应用

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摘要

A stability indicating reverse phase high performance liquid chromatography method has been developed for the estimation of Dronedarone in tablet dosage form. A symmetry C18 column having dimensions of 150×4.6mm and 3μm particle size, with mobile phase containing a mixture of acetonitrile and phosphate buffer in the ratio of 60:40 v/v was used. PH of mobile phase was adjusted to 6.8 with sodium hydroxide. The flow rate was 1ml/min and the column effluents were monitored at 290 nm. The retention time for Dronedarone was found to be 2.65min. The proposed method was validated in terms of linearity, accuracy, precision, LOD, LOQ and robustness. The LOD and LOQ were found to be 0.018μg/ml and 0.06μg/ml respectively. The method was found to be linear in the range of 10 – 50 μg/ml with regression coefficient (r = 0.9996). The % recovery for the Dronedarone was found to be 99.6 and the forced degradation studies were also carried out as per ICH guidelines. There was complete separation of degradation peak and Dronedarone peak, which demonstrate the specificity of assay method for estimation of Dronedarone in the presence of its degradation products; it can be employed as a stability indicating one. Due to simplicity, rapidity and accuracy of the proposed stability indicating HPLC method is useful for quality control analysis.
机译：已经开发了一种指示片剂中决奈达隆的指示稳定性的反相高效液相色谱方法。使用尺寸为150×4.6mm，粒径为3μm的对称C18色谱柱，流动相中含有比例为60:40 v / v的乙腈和磷酸盐缓冲液的混合物。用氢氧化钠将流动相的PH调节至6.8。流速为1ml / min，并在290 nm处监测柱流出物。发现决奈达隆的保留时间为2.65min。该方法在线性，精度，精度，LOD，LOQ和鲁棒性方面得到了验证。 LOD和LOQ分别为0.018μg/ ml和0.06μg/ ml。发现该方法在10 – 50μg/ ml范围内是线性的，具有回归系数（r = 0.9996）。发现决奈达隆的回收百分率为99.6，并且还按照ICH指南进行了强制降解研究。降解峰和决奈达隆峰完全分离，表明在降解产物存在下评估决奈达隆的测定方法的特异性。它可以用作指示稳定性的一种。由于简单性，所提出的稳定性指示HPLC方法的快速性和准确性可用于质量控制分析。

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