Volume : 09, Issue : 10, October – 2022

Title:

52.METHOD DEVELOPMENT AND VALIDATION OF REMDESIVIR BY USING RP HPLC METHOD

Authors :

Shravani, K. Tirumala

Abstract :

A simple, precision and accuracy HPLC method was developed the estimation of Remdesivir analysis of formulation, consisting of an Methanol: water (60: 40 % v/v). The chromatographic condition was set at a Flow rate of 1 ml/min with the UV detector at 240 nm. The above method was optimized with a view to develop an assay method for Remdesivir. Several mobile phase compositions were tried to resolve the peaks of Remdesivir. The optimum mobile phase containing methanol: water (60: 40 % v/v) was selected because it was found ideal to resolve the analyte peaks of the drug. Quantification was achieved with UV detections at 240 nm based on peak area and absorbence. As per USP requirements system suitability studies were carried out and freshly prepared standard solutions of Remdesivir.
Keywords: Remdesivir, RP‐HPLC, Method development, Validation

Cite This Article:

Please cite this article in press K. Tirumala et al, Method Development And Validation Of Remdesivir By Using RP HPLC Method ., Indo Am. J. P. Sci, 2022; 09(10).

References:

1. FDA Approved Drug Products: VEKLURY (remdesivir) injection, for intravenous use
2. Gordon CJ, Tchesnokov EP, Woolner E, Perry JK, Feng JY, Porter DP, Gotte M: Remdesivir is a direct-acting antiviral that inhibits RNA-dependent RNA polymerase from severe acute respiratory syndrome coronavirus 2 with high potency. J Biol Chem. 2020 May 15;295(20):6785-6797. doi: 10.1074/jbc.RA120.013679. Epub 2020 Apr 13. (PubMed ID 32284326)
3. R Siva Kumar, K V Sravan Kumar, L Kondareddy, K R Yogeshwara, Gangrade Manish, Jayachandran Jeenet, Kanyawar Nitesh, Stability Indicating RP-HPLC Method for Estimation of Potential Impurities in Ledipasvir and Characterization of a New Degradation Impurity, Journal of Chromatographic Science, Volume 56, Issue 5, May 2018, Pages 383–395.
4. Shaik, Dr. Abdul & Khaleel, N.. (2020). Development and Validation of Novel Stability indicating RP-HPLC Method for Quantification of Tolvaptan in Bulk and Pharmaceutical Dosage Form. Indian Drugs. 57. 62-68. 10.53879/id.57.03.11817.
5. Dongala T, Katari NK, Palakurthi AK, Katakam LNR, Marisetti VM. Stability Indicating LC Method Development for Hydroxychloroquine Sulfate Impurities as Available for Treatment of COVID-19 and Evaluation of Risk Assessment Prior to Method Validation by Quality by Design Approach. Chromatographia. 2020;83(10):1269-1281.
6. Ibrahim bulduk. HPLC-UV method for quantification of favipiravir in pharmaceutical formulations. Acta Chromatographica. 33 (2021) 3, 209–215.
7. Huda NH, Gauri B, Benson HAE, Chen Y. A Stability Indicating HPLC Assay Method for Analysis of Rivastigmine Hydrogen Tartrate in Dual-Ligand Nanoparticle Formulation Matrices and Cell Transport Medium. J Anal Methods Chem. 2018