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首页> 外文期刊>Cogent Chemistry >Ultra performance liquid chromatographic method for simultaneous quantification of plerixafor and related substances in an injection formulation
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Ultra performance liquid chromatographic method for simultaneous quantification of plerixafor and related substances in an injection formulation

机译：超高效液相色谱法同时定量注射制剂中的培乐沙福及相关物质

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AbstractPlerixafor (PLX) injections are administered to patients with cancers of lymphocytes (non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main objective of the current study was to develop a short reverse phase chromatographic method for the simultaneous quantification of PLX and its impurities, in an injection formulation, to reduce the time required for these quality tests. Furthermore, the present work describes the role of nonalkyl branched nonquaternary ion pair reagent in improving the peak shape and reducing column equilibration time. The separation of PLX and its related substances is pH dependent (optimum pH?=?2.50) and was achieved on an octadecylsilyl (C18) column. The method was validated for its intended purpose in accordance with the current regulatory guidelines for validation. The proposed method can be applied for quality control, release, and stability analyses of active pharmaceutical ingredient, PLX, as well as finished products, PLX injections.
机译：摘要Plerixafor（PLX）注射剂用于患有淋巴细胞（非霍奇金淋巴瘤）和浆细胞（多发性骨髓瘤）癌症的患者。当前研究的主要目的是开发一种短反相色谱方法，用于同时定量注射制剂中的PLX及其杂质，以减少这些质量测试所需的时间。此外，本工作描述了非烷基支化非季铵离子对试剂在改善峰形和减少色谱柱平衡时间方面的作用。 PLX及其相关物质的分离取决于pH（最适pH≤2.50），并且是在十八烷基甲硅烷基（C18）柱上实现的。该方法已根据当前的法规验证指南进行了预期用途验证。该方法可用于活性药物成分PLX以及最终产品PLX注射剂的质量控制，释放和稳定性分析。

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