TY - JOUR AU - Kavitha, A. N. PY - 2020/11/28 Y2 - 2024/03/28 TI - A New Validated RP-HPLC Method for the Estimation of Darunavir Ethanolate in Bulk and Tablets JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 14 IS - 4 SE - ORIGINAL ARTICLES DO - 10.22377/ajp.v14i4.3834 UR - https://www.asiapharmaceutics.info/index.php/ajp/article/view/3834 SP - AB - <p>Objective: Darunavir ethanolate is the last United States Food and Drug Administration approved protease<br />inhibitor (PI). The drug is used along with other PIs (ritonavir/cobicistat) for the effective management of<br />human immunodeficiency virus (HIV) HIV-1 infection. Darunavir ethanolate exerts its action by binding noncompetitively<br />to HIV protease enzyme. The main objective of the present research work was to develop a new<br />profound and novel reverse-phase high-performance liquid chromatography (RP-HPLC) for the estimation of<br />darunavir ethanolate. Methods: As per the guidelines of the Food and Drug Administration and International<br />Council for harmonization, the method was validated. The HPLC analysis was performed on the waters 2695<br />equipped with symmetry C18 column 3.5 μm, 150 mm × 4.6 mm, with a mixture of acetonitrile:0.1% phosphate<br />buffer (50:50 V/V) as the mobile phase, at the flow rate of 1 ml/min. The total run time was 5 min and the<br />detection was performed at the wavelength (λ) of 262 nm. Results: The retention time for darunavir ethanolate<br />was found to be 2.269 min. The standard curves were obtained with R2 0.9997 and linear at the concentration<br />range of 8–120 μg/ml. The limit of quantitation and limit of detection for darunavir ethanolate were found to<br />be 0.08 μg/ml and 0.8 μg/ml, respectively. The method’s accuracy was tested by percentage recovery tests and<br />found to be 100.3%. The results obtained were within the accepted standards for linearity, accuracy, precision,<br />specificity, and robustness. Conclusion: The proposed RP-HPLC method can be applied for the routine analytical<br />estimation of darunavir ethanolate in bulk and tablet formulations.</p> ER -