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1Student of Loknete Shri Dadapatil Pharate College of Pharmacy, Mandavgan Pharata.
2Principal of Loknete Shri Dadapatil Pharate College of Pharmacy, Mandavgan Pharata.
3Associate Prof. of Loknete Shri Dadapatil Pharate College of Pharmacy, Mandavgan Pharata.
4Associate Prof. of Loknete Shri Dadapatil Pharate College of Pharmacy, Mandavgan Pharata.
5Assistant Prof. of Dr B B Khaladkar College of Pharmacy, Wakhari
Remdesivir is a broad-spectrum antiviral nucleotide analogue that gained significant importance during the COVID-19 pandemic due to its efficacy against SARS-CoV-2. Accurate and reliable analytical methods are essential for the qualitative and quantitative determination of Remdesivir in pharmaceutical formulations and biological matrices. Among various analytical techniques, Reverse Phase High Performance Liquid Chromatography (RP-HPLC) remains the most widely employed method because of its simplicity, sensitivity, precision, and cost-effectiveness. Recent advancements have also introduced LC-MS/MS, UPLC, and green analytical approaches for improved sensitivity and environmental sustainability. This review summarizes the current analytical methodologies developed for Remdesivir estimation, including chromatographic conditions, validation parameters, stability-indicating methods, and bioanalytical applications. The review also discusses method validation according to ICH guidelines and highlights future trends in analytical research for antiviral drug analysis.
Remdesivir is a nucleotide analogue prodrug developed for the treatment of RNA viral infections. It acts by inhibiting RNA-dependent RNA polymerase, thereby preventing viral replication. The drug demonstrated remarkable therapeutic potential during the COVID-19 pandemic and became one of the first antiviral agents approved for clinical use against SARS-CoV-2. Due to its extensive pharmaceutical applications, reliable analytical methods are required for quality control, stability assessment, and pharmacokinetic studies.
Remdesivir is a nucleotide analogue prodrug developed for the treatment of RNA viral infections. Its antiviral activity is mediated through inhibition of RNA-dependent RNA polymerase (RdRp), which disrupts viral RNA synthesis and prevents viral replication. The drug gained significant attention during the COVID-19 pandemic owing to its demonstrated therapeutic efficacy against COVID-19 and became one of the first antiviral agents approved for the treatment of infections caused by COVID-19. Given its widespread clinical use and pharmaceutical importance, the development of reliable analytical methods is essential for quality control, stability evaluation, pharmacokinetic investigations, and regulatory compliance.
2. REMDESIVIR: DRUG OVERVIEW
Figure 1: Chemical Structure of Remdesivir
Figure 2: Mechanism of Action of Remdesivir
Figure 3: Schematic Representation of RP-HPLC System
Flow: Mobile Phase Reservoir → Degasser → Pump → Injector/Autosampler → C18 Reverse-Phase Column → UV/PDA Detector → Data System → Chromatogram Output.
3. ANALYTICAL TECHNIQUES FOR REMDESIVIR ESTIMATION
3.1 UV Spectrophotometric Methods
UV-visible spectrophotometry is a simple and economical analytical technique used for preliminary drug estimation. Several methods have been reported for Remdesivir quantification in bulk and formulations.
Advantages:
Limitations:
3.2 RP-HPLC METHODS
RP-HPLC is the most frequently used analytical technique for Remdesivir determination.
Common Chromatographic Conditions:
Advantages:
4. METHOD VALIDATION ACCORDING TO ICH GUIDELINES
Validation Parameters:
Acceptance Criteria:
5. STABILITY INDICATING METHODS
Stability studies are performed under:
Stability-indicating methods help identify degradation products and ensure product safety throughout shelf life.
6. BIOANALYTICAL METHODS
LC-MS/MS techniques have become highly important for pharmacokinetic and bioavailability studies.
Advantages:
7. GREEN ANALYTICAL APPROACHES
Recent studies emphasize environmentally friendly analytical methods using:
These approaches align with sustainable pharmaceutical analysis.
8. FUTURE PERSPECTIVES
Future analytical research should focus on:
9. CONCLUSION
The present study entitled “Determination of Remdesivir Using a Validated RPHPLC Method in Bulk and Pharmaceutical Formulations” was successfully carried out with the objective of developing a reliable analytical method for the estimation of Remdesivir. A simple, rapid, and efficient RP-HPLC method was developed using a C18 column with a mobile phase consisting of Acetonitrile and 0.1% Orthophosphoric acid (60:40 v/v, pH 3.2). The method showed a well-defined peak for Remdesivir with a retention time of approximately 3.27 minutes, indicating a fast and effective separation. The developed method was validated according to ICH Q2(R1) guidelines. The validation parameters, including system suitability, linearity, accuracy, precision, specificity, robustness, LOD, and LOQ, were found to be within acceptable limits. The method exhibited excellent linearity over the concentration range of 10–60 µg/mL with a high correlation coefficient (R² = 0.9998). The accuracy studies demonstrated recovery close to 100%, and precision studies showed %RSD values less than 2%, confirming the reliability of the method. The method was found to be specific, as no interference from excipients was observed at the retention time of Remdesivir. Robustness studies confirmed that small variations in experimental conditions did not significantly affect the analytical performance. The sensitivity of the method was adequate, with low LOD and LOQ values. The developed method was successfully applied for the estimation of Remdesivir in pharmaceutical formulation, and the assay results were found to be within acceptable limits (approximately 99.96% of the labeled claim). In conclusion, the proposed RP-HPLC method is simple, accurate, precise, sensitive, robust, and cost-effective, making it highly suitable for routine quality control analysis of Remdesivir in bulk drug and pharmaceutical dosage forms.
REFERENCES
Shamali Sonawane, Hemant Kamble, P. Jadhav, Sugriv Ghodake, Shubham Dhavale, A Review on: Determination of Remdesivir Using a Validated RP-HPLC (Reversed-Phase High- Performance Liquid Chromatography) Method in Bulk and Pharmaceutical Formulations, Int. J. of Pharm. Sci., 2026, Vol 4, Issue 6, 5122-5128. https://doi.org/10.5281/zenodo.20766412
10.5281/zenodo.20766412