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@article{191551,
author = {M ASHOKBABU and G SHAILAJA and K VANITHA PRAKASH},
title = {DEVELOPMENT AND VALIDATION ANALYTICAL RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF NIRMATRELVIR AND RITONAVIR IN API FORM AND PHARMACEUTICAL DOSAGE FORM},
journal = {International Journal of Innovative Research in Technology},
year = {2026},
volume = {12},
number = {8},
pages = {7652-7662},
issn = {2349-6002},
url = {https://ijirt.org/article?manuscript=191551},
abstract = {A new, simple, precise, accurate and reproducible RP-HPLC method for Simultaneous estimation of Nirmatrelvir and Ritonavir in bulk and marketed pharmaceutical formulations. Separation of Nirmatrelvir and Ritonavir was successfully achieved on an X-Terra (4.6 ×150mm, 5µm particle size) in an isocratic mode utilizing Methanol: Acetonitrile: Water (50:35:15% v/v/v) at a flow rate of 1.0mL/min and eluates was monitored at 280nm, with a retention time of 1.689 and 3.238 minutes for Nirmatrelvir and Ritonavir respectively. The method was validated and the response was found to be linear in the drug concentration range of 20µg/mL to 100µg/mL for Nirmatrelvir and 5µg/mL to 25µg/mL for Ritonavir respectively. The values of the slope and the correlation coefficient were found to be 22649 and 0.999 for Nirmatrelvir and 19445 and 0.9991 for Ritonavir respectively. The LOD and LOQ for Nirmatrelvir were found to be 2.58µg/mL and 7.84µg/mL respectively. The LOD and LOQ for Ritonavir were found to be 1.08 µg/mL and 3.27µg/mL respectively. This method was found to be good %recovery for Nirmatrelvir and Ritonavir were found to be 99.3 and 100.7 respectively indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard with the sample so, the method specifically determines the analytes in the sample without interference from excipients of tablet dosage forms. The method was extensively validated according to ICH guidelines for Linearity, Range, Accuracy, Precision, Specificity and Robustness.},
keywords = {Nirmatrelvir and Ritonavir, HPLC, Method Development, Accuracy, Validation.},
month = {January},
}
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