Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment
Abstract RP-HPLC technique was developed and optimized for simultaneous identification and estimation of nirmatrelvir (NIR) and ritonavir (RIT) in their new copackaged tablet. Stability of nirmatrelvir (NIR) was studied after exposure to different five stress conditions; alkali, acid, heat, photo an...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2025-01-01
|
| Series: | Scientific Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1038/s41598-025-85776-8 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832594833677484032 |
|---|---|
| author | Mohamed G. Yassin Aya Roshdy Aya A. Marie |
| author_facet | Mohamed G. Yassin Aya Roshdy Aya A. Marie |
| author_sort | Mohamed G. Yassin |
| collection | DOAJ |
| description | Abstract RP-HPLC technique was developed and optimized for simultaneous identification and estimation of nirmatrelvir (NIR) and ritonavir (RIT) in their new copackaged tablet. Stability of nirmatrelvir (NIR) was studied after exposure to different five stress conditions; alkali, acid, heat, photo and oxidation degradation. The chromatographic separation was achieved using VDSpher PUR 100 ODS (4.6-mm x 15-mm), 3.5 μm column and mixture of 0.03 M potassium di-hydrogen phosphate buffer pH 4 and acetonitrile (45:55, v/v) as mobile phase. The column temperature was set at 40 °C, flow rate at 1mL/min and UV detection at 215 nm. The NIR and RIT retention times were 3.94 ± 0.08 min and 9.08 ± 0.1 min, respectively. Linear relationship was established in range of (1.5–105 µg/mL) for NIR and (1–70 µg/mL) for RIT with good reproducibility. The found mean percentage recoveries of nirmatrelvir (NIR) and ritonavir (RIT) were 100.03% and 99.85%, respectively. The developed method shows very good sensitivity as the LOQ and LOD were found to be 3.001 & 0.990 µg/mL, respectively for NIR and 2.765 & 0.912 µg/mL, respectively for RIT. The developed approach was validated concerning to ICH guidelines and applied successfully for the simultaneous estimation of NIR and RIT in their new copackaged dosage from. The results of assay using the proposed approach were compared statistically to the results found by applying the published one with good agreement. |
| format | Article |
| id | doaj-art-678a92cbbea2498cadc839de691f7113 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-678a92cbbea2498cadc839de691f71132025-01-19T12:19:07ZengNature PortfolioScientific Reports2045-23222025-01-011511910.1038/s41598-025-85776-8Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatmentMohamed G. Yassin0Aya Roshdy1Aya A. Marie2Zeta Pharma for Pharmaceutical IndustriesPharmaceutical Chemistry Department, Faculty of Pharmacy, Horus UniversityPharmaceutical Chemistry Department, Faculty of Pharmacy, Horus UniversityAbstract RP-HPLC technique was developed and optimized for simultaneous identification and estimation of nirmatrelvir (NIR) and ritonavir (RIT) in their new copackaged tablet. Stability of nirmatrelvir (NIR) was studied after exposure to different five stress conditions; alkali, acid, heat, photo and oxidation degradation. The chromatographic separation was achieved using VDSpher PUR 100 ODS (4.6-mm x 15-mm), 3.5 μm column and mixture of 0.03 M potassium di-hydrogen phosphate buffer pH 4 and acetonitrile (45:55, v/v) as mobile phase. The column temperature was set at 40 °C, flow rate at 1mL/min and UV detection at 215 nm. The NIR and RIT retention times were 3.94 ± 0.08 min and 9.08 ± 0.1 min, respectively. Linear relationship was established in range of (1.5–105 µg/mL) for NIR and (1–70 µg/mL) for RIT with good reproducibility. The found mean percentage recoveries of nirmatrelvir (NIR) and ritonavir (RIT) were 100.03% and 99.85%, respectively. The developed method shows very good sensitivity as the LOQ and LOD were found to be 3.001 & 0.990 µg/mL, respectively for NIR and 2.765 & 0.912 µg/mL, respectively for RIT. The developed approach was validated concerning to ICH guidelines and applied successfully for the simultaneous estimation of NIR and RIT in their new copackaged dosage from. The results of assay using the proposed approach were compared statistically to the results found by applying the published one with good agreement.https://doi.org/10.1038/s41598-025-85776-8Nirmatrelvir (NIR)Ritonavir (RIT)RP-HPLCStability indicatingCopackaged tablet |
| spellingShingle | Mohamed G. Yassin Aya Roshdy Aya A. Marie Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment Scientific Reports Nirmatrelvir (NIR) Ritonavir (RIT) RP-HPLC Stability indicating Copackaged tablet |
| title | Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment |
| title_full | Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment |
| title_fullStr | Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment |
| title_full_unstemmed | Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment |
| title_short | Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment |
| title_sort | stability indicating rp hplc technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for covid 19 treatment |
| topic | Nirmatrelvir (NIR) Ritonavir (RIT) RP-HPLC Stability indicating Copackaged tablet |
| url | https://doi.org/10.1038/s41598-025-85776-8 |
| work_keys_str_mv | AT mohamedgyassin stabilityindicatingrphplctechniqueforsimultaneousestimationofnirmatrelvirandritonavirintheirnewcopackageddosageformforcovid19treatment AT ayaroshdy stabilityindicatingrphplctechniqueforsimultaneousestimationofnirmatrelvirandritonavirintheirnewcopackageddosageformforcovid19treatment AT ayaamarie stabilityindicatingrphplctechniqueforsimultaneousestimationofnirmatrelvirandritonavirintheirnewcopackageddosageformforcovid19treatment |