Development and validation of stability indicating methods for the simultaneous estimation of antiviral drugs Darunavir and Ritonavir by RP-HPLC in Bulk and Dosage Forms

Radha Khambhampati, Sireesha Dodda, Rajendra Kumar Jadi

Article ID: 2337
Vol 7, Issue 1, 2024

VIEWS - 117 (Abstract) 0 (Untitled) 43 (PDF)

Abstract


We have successfully developed and validated a reliable method using reversed phase high performance liquid chromatography (RP-HPLC) that accurately determines stability, amounts of darunavir and ritonavir, in both their pure and dosage form. To achieve this, we utilized a Phenomenex C18 column with dimensions of 250 × 4.6 mm and a particle size of 5 μm. By pumping methanol as mobile phase through the column, at a flow rate of 1mL/min we were able to achieve results. The detection was performed at the wavelengths of 265 nm and 238 nm, for darunavir and ritonavir respectively using PDA detector. The retention times of darunavir and ritonavir were found to be 2.696 and 3.031 min respectively. Linearity was established in concentration range of 10 to 100 µg/mL with r2 ≥ 0.99. This method shows good precision results, the percentage RSD was found to be 0.965 and 1.429. The % recovery was obtained as 99.70 % and 98.83 % for darunavir and ritonavir respectively. The LOD and LOQ values were found to be 4.36 µg/mL and 13.20 µg/mL for darunavir and 4.97 µg/mL and 15.05 µg/mL for ritonavir, respectively.


Keywords


Darunavir; ritonavir; RP-HPLC; method development; validation

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DOI: https://doi.org/10.24294/ace.v7i1.2337

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