Paper Title
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR NIRMATRELVIR AND RITONAVIR IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD
Article Identifiers
Authors
Baban S Satpute , Sagar S. Kale , Amar A. Jadhav , Aishwarya A. Ubale , Yogita M. Mane
Keywords
Analytical Method Development, ICH Q2 (R1), Nirmatrelvir , Ritonavir.
Abstract
The purpose of this study was to develop and validate a simple, sensitive, accurate, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of Nirmatrelvir and Ritonavir in a Tablet dosage form. Nirmatrelvir and ritonavir were separated on a Agilent Poroshell EC 120 C18 (150 x 4.6 mm, 4 µ) column with mobile phase Water: Methanol (35:65 %, v/v). The flow rate was 1 mL/min and detection wavelength from the overlain spectra was 250 nm for Ritonavir and Nirmatrelvir were selected for analysis. Method linearity was established over a range of 12–18 μg/mL for nirmatrelvir and 8–12 μg/mL for ritonavir. LOD and LOQ for nirmatrelvir was 1.25 and 3.85 μg/mL and 0.34 and 1.12 μg/mL for ritonavir. The correlation coefficients ('r' values) for Nirmatrelvir and Ritonavir were 0.998 and 0.999, respectively. The recovery (%) was 99.78 to 100.99 (Nirmatrelvir) and 100.00 to 101.10 (Ritonavir). Method was suitable to assay nirmatrelvir and ritonavir in tablet formulation. Stress degradation studies have shown that this method can be implemented to assay nirmatrelvir and ritonavir in the presence of its degradants.
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How To Cite (APA)
Baban S Satpute , Sagar S. Kale, Amar A. Jadhav , Aishwarya A. Ubale, & Yogita M. Mane (June-2024). ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR NIRMATRELVIR AND RITONAVIR IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(6), c753-c774. https://ijnrd.org/papers/IJNRD2406269.pdf
Issue
Volume 9 Issue 6, June-2024
Pages : c753-c774
Other Publication Details
Paper Reg. ID: IJNRD_223718
Published Paper Id: IJNRD2406269
Downloads: 000122011
Research Area: Pharmacy
Country: Akluj, Maharashtra, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2406269.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2406269
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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)
ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016
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This work is licensed under a Creative Commons Attribution 4.0 International License and The Open Definition
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