特立氟米特有效成分反相高效液相色谱分析方法的建立与验证

Arun Maruti Kashid, Pranali Prakash Polshettiwar, Kshitija Maruti Bhosale
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引用次数: 1

摘要

药物分析在药物的发现、生产和治疗使用中是至关重要的。药典中可能没有新药物或新制剂的标准分析方法;因此,必须发展准确、精确、专一、线性、简单、快速的新型分析方法。建立了一种快速、简便、灵敏、精确、经济高效的特立氟米特原料药(API)的反相高效液相色谱测定方法。采用反相高效液相色谱法测定特立氟米特,色谱柱为Sunniest C18 (250mm × 4.6mm, 5μm),流动相为ACN: Water,比例为60:40 v/v。流动相以等压流速1.0ml/min给药。在210nm处进行紫外检测。最佳保留时间为4小时。4分钟。特立氟米特浓度在35 ~ 247µg/ml范围内呈线性关系,相关系数为0.999。定量限和定量限分别为1.61µg/ml和4.90µg/ml,精密度RSD < 2%。结果表明,回收率范围满足要求。通过改变流速和流动相组成进行稳健性研究。验证了该方法的系统适用性、专属性、线性度、精密度、准确度、检出限、定量限和鲁棒性。该方法可用于特立氟米特原料药的质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC
Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.
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