Varada Soujanya and Revu Baby Nalanda*

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), India

*Corresponding Author: Revu Baby Nalanda, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), India.

Received: May 24, 2024; Published: May 31, 2024

Abstract

An efficient and reliable RP-HPLC technique has been developed specifically for the detection and quantification of Nirmatrelvir and its related impurities in pharmaceutical formulations. Waters UPLC Aqcuity system with TUV detector integrated with Empower 2 Software with Agilent C18 column C18 column (5 μm, 4.6 mm X 250 mm) using mobile phase of 0.01N phosphate buffer: Methanol (55:45 v/v) with flow rate 1 ml/min (Detection wavelength 223 nm are the optimised chromatographic conditions for the present study. Degradation studies were performed for Nirmatrelvir drug and its related impurities and the method was validated as per ICH guidelines.

Keywords: Nirmatrelvir; Nirmatrelvir Acid Impurity; Trifluoro Bicycloamide Impurity; Validation; ICH Guidelines

References

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Citation

Citation: Varada Soujanya and Revu Baby Nalanda. “A New Validated Stability Indicating RP-HPLC Method for the Estimation of Nirmatrelvir and its Related Impurities".Acta Scientific Pharmaceutical Sciences 8.6 (2024): 110-114.

Copyright

Copyright: © 2024 Varada Soujanya and Revu Baby Nalanda. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.