Research and Development Centre, Bharathiar University, Coimbatore 641046, Tamil Nadu, India.
Research and Development Centre, Department of Chemistry, Shridevi Institute of Engineering and Technology, Tumkur 572106, Karnataka, India.
J Chromatogr Sci. 2022 Feb 16;60(2):194-200. doi: 10.1093/chromsci/bmab042.
An effectual and stability signifying technique has been validated for the quantitative verification of degradation products in Remdesivir Injectable pharmaceutical products by employing high-performance liquid chromatography with ultraviolet detector. The process was optimized by using an octyldecylsilane chemically bonded column (Kromasil KR100-5 C18; USP L1 phase) with dimensions; 250 mm length × 4.5 mm inner diameter and 5-μm particle size. The method was validated as per International Conference on Harmonization and other current regulatory guidelines for analytical method validation. The anticipated process was found to be robust, accurate, specific, linear, precise, stable and rugged in the concentration ranging from quantification level to 200% of the specification level of specified and unknown degradation impurities. The technique was effectively applied to analyze degradation products in Remdesivir Injectable drug products.
高效液相色谱法-紫外检测法用于定量检测雷迪西韦注射剂中降解产物，该方法已被验证为有效且稳定的检测方法。采用辛基硅烷键合柱（Kromasil KR100-5 C18；USP L1 相），柱长 250mm，内径 4.5mm，粒径 5μm，对该方法进行了优化。方法按照国际协调会议和其他现行法规指南进行了分析方法验证。研究发现，该方法在定量下限到规定和未知降解杂质 200%的浓度范围内具有较强的耐用性、准确性、特异性、线性、精密度、稳定性和耐用性。该技术已成功应用于分析雷迪西韦注射剂中的降解产物。
