A Novel Liquid Chromatographic Method for the Quantitative Determination of Degradation Products in Remdesivir Injectable Drug product. (5th May 2021)

• Record Type: Journal Article
• Authors: Reddy, H Ramakrishna; Pratap, S R; Chandrasekhar, N; Shamshuddin, S Z M
• Is Part Of: Journal of chromatographic science. Volume 60:Number 2(2022)
• Page Start: 194
• Page End: 200
• Publication Date: 2021-05-05
• Subjects: Chromatographic analysis -- Periodicals; 543.8
• DOI: 10.1093/chromsci/bmab042
• Languages: English
• ISSNs: 0021-9665

Abstract

Abstract: 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.