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首页> 美国卫生研究院文献>Journal of Pharmaceutical Analysis >A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode
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A validated stability-indicating LC method for the separation of enantiomer and potential impurities of Linezolid using polar organic mode

机译：经验证的稳定性指示LC方法用于极性有机模式分离利奈唑胺的对映异构体和潜在杂质

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摘要

Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm×4.6 mm, 5 μm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.
机译：尽管有许多方法可以评估利奈唑胺及其可能的杂质，但如果仍然无法以一种高效的单一方法分离潜在的杂质，降解物和对映异构体，则可以采用一种通用的分离方法。为了开发一种运行时间更短的先进方法，开发了一种简单，精确，准确的稳定性指示LC方法，用于在杂质存在的情况下测定散装样品和药物剂型中的利奈唑胺原料药和药物的纯度和降解产物。该方法能够分离利奈唑胺的所有相关物质以及手性杂质。该方法还可用于估计原料药和药品中利奈唑胺的含量。该方法是使用Chiralpak IA（250mm×4.6mm，5μm）色谱柱开发的。比例为96：4：0.10：0.16（v / v / v / v）的乙腈，乙醇，正丁胺和三氟乙酸的混合物用作流动相。洗脱的化合物在254 nm处进行监测。利奈唑胺受到氧化，酸，碱，水解，热和光解降解的胁迫条件。从主峰及其杂质中可以很好地分离降解产物，证明了该方法的稳定性。根据国际协调大会（ICH）指南，针对特异性，检测限，定量限，精确度，线性，准确性，鲁棒性和系统适用性，对开发的方法进行了验证。

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