Volume 10 ; Issue 2 ; in Month : July-Dec (2026) Article No : 207
Kumar R, Pawar M, Sarankar SK.

Abstract

Background: Remdesivir is an antiviral nucleotide analogue used in the management of COVID-19. Reliable analytical procedures are essential for quantitative determination of remdesivir in pharmaceutical products and for routine quality-control analysis. Objective: The present study aimed to develop and validate a simple, precise, accurate, specific, sensitive, robust and rugged RP-HPLC method for quantitative determination of remdesivir in bulk drug and pharmaceutical dosage form. Methods: Chromatographic method development was performed using a reversed-phase C18 column. Different mobile-phase compositions and chromatographic conditions were evaluated to obtain satisfactory peak shape and chromatographic performance. The final validated method employed a C18 column (250 × 4.6 mm, 5 µm) with phosphate buffer (0.02 M, pH 3.5):acetonitrile (60:40, v/v) as an isocratic mobile phase at a flow rate of 1.0 mL/min. Detection was performed at 245 nm with an injection volume of 20 µL and a total run time of 6 min. The method was validated for system suitability, specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness and ruggedness. Results: The developed method produced a well-defined remdesivir peak at a mean retention time of 5.82 min. System-suitability assessment demonstrated a mean theoretical plate count of 5467 and a mean tailing factor of 1.09, with retention-time %RSD of 0.12%. The method was linear over the concentration range of 5–50 µg/mL Mean recovery was 99.57%. Intra-day and inter-day precision showed %RSD values of 0.10% and 0.12%, respectively. LOD and LOQ were 0.095 and 0.287 µg/mL, respectively. No significant interference from blank or placebo was observed at the remdesivir retention region. Ruggedness studies using different analysts and instruments also demonstrated satisfactory reproducibility. Conclusion: The validated RP-HPLC method demonstrated satisfactory specificity, linearity, accuracy, precision, sensitivity, robustness and ruggedness. The method is simple and suitable for routine quantitative determination of remdesivir in bulk drug and pharmaceutical dosage forms.

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