@article{SATHESHKUMAR_MURUGANANTHAM_2020, title={A SIMPLE AND RUGGED BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BRIVUDINE IN HUMAN PLASMA BY USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY}, volume={12}, url={https://journals.innovareacademics.in/index.php/ijpps/article/view/37703}, DOI={10.22159/ijpps.2020v12i7.37703}, abstractNote={<p><strong>Objective: </strong>The current research work focus to simple and rugged bioanalytical method development and validation of brivudine in human plasma using high-performance liquid chromatography.</p> <p><strong>Methods: </strong>The analyte (Brivudine) and internal standard (Sofosbuvir) were extracted using the Solid Phase Extraction (SPE) technique. The chromatographic separation was accomplished by using Zorbax eclipse XDB-C<sub>18</sub> Column (150×4.6 mm, 5 μm) with a mobile phase consisted of Methanol: 0.5% Ortho-phosphoric acid (65:35%, v/v) respectively, at a flow rate of 0.7 mL/min. The developed method was validated by performing system suitability, carryover effect, linearity, selectivity, sensitivity, precision, accuracy, recovery, ruggedness, and stability studies. The method was validated as per USFDA guidelines.</p> <p><strong>Results: </strong>The selected chromatographic condition was found to efficiently separated brivudine (RT-3.55 min) and ISTD (RT-7.87 min). The assay demonstrated a linear dynamic range of 85.205 to 4500.246 ng/ml for brivudine in human plasma with r<sup>2</sup>>0.99. Demonstrated the lowest limit of detection at 85.205 ng/ml. This method established an intra-run and inter-run precision within the range of 2.99-6.31%CV and 3.67-5.80%CV, respectively. Additional intra-run and inter-run accuracy were within the range of 97.55-105.37% and 99.27-102.15%, respectively. The mean percentage recovery of brivudine and ISTD studies proved good extraction efficiency and the robustness was also evaluated.</p> <p><strong>Conclusion: </strong>A simple, accurate, precise, linear and rugged RP-HPLC method was developed and validated for the estimation of brivudine in human plasma with K<sub>2</sub>EDTA anticoagulant and suitable for conducting BA/BE and TDM.</p>}, number={7}, journal={International Journal of Pharmacy and Pharmaceutical Sciences}, author={SATHESHKUMAR, S. and MURUGANANTHAM, V.}, year={2020}, month={Jul.}, pages={45–50} }