ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR NIRMATRELVIR AND RITONAVIR IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR NIRMATRELVIR AND RITONAVIR IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD

Registration ID: IJNRD_223718

Published ID: IJNRD2406269

DOI: Click Here to Get

Baban S Satpute , Sagar S. Kale , Amar A. Jadhav , Aishwarya A. Ubale , Yogita M. Mane

Analytical Method Development, ICH Q2 (R1), Nirmatrelvir , Ritonavir.

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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"ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR NIRMATRELVIR AND RITONAVIR IN COMBINED TABLET DOSAGE FORM BY USING SIMULTANEOUS ESTIMATION METHOD", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 6, page no.c753-c774, June-2024, Available :https://ijnrd.org/papers/IJNRD2406269.pdf

Volume 9 Issue 6, June-2024

Pages : c753-c774

Paper Reg. ID: IJNRD_223718

Published Paper Id: IJNRD2406269

Downloads: 000121250

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

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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