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RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF REMDESIVIR IN IV FORMULATION (Record no. 132520)
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| 000 -LEADER | |
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| fixed length control field | 01600nam a2200145 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250821b |||||||| |||| 00| 0 eng d |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Mukesh P. Ratnaparkhi |
| 245 ## - TITLE STATEMENT | |
| Title | RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF REMDESIVIR IN IV FORMULATION |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | Page No. 45-49 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. biblio.abstract | The overall effect of the SARS-CoV-2 virus, instigating COVID-19, has highlighted the urgent need for effective treatments. Remdesivir, the only FDA-approved antiviral for severe COVID-19 in adults and children, requires precise analytical methods for its pharmaceutical formulation. Current HPLC techniques exist, but there is a critical demand for more efficient and accurate approaches. The current study addresses this need by developing and validating a specific HPLC method for quantitative analysis in an IV dosage form for remdesivirs. Utilizing a C18 column with a 0.7 mL min- ยน flow rate, the analysis was completed in 10 minutes with an isocratic mobile phase of 50:50 V/V acetonitrile and methanol. Validation followed ICH Q2 (R2) guidelines, confirming the method's suitability, linearity, precision, accuracy and robustness. The results indicate that this HPLC method is straightforward, efficient and highly sensitive, making it a valuable tool for ensuring the quality and efficacy of remdesivir. |
| 654 ## - SUBJECT ADDED ENTRY--FACETED TOPICAL TERMS | |
| Subject | <a href="COVID-19">COVID-19</a> |
| -- | <a href="RP-HPLC">RP-HPLC</a> |
| -- | <a href="method development and validation">method development and validation</a> |
| -- | <a href="remdesivir ">remdesivir </a> |
| -- | <a href="quantification">quantification</a> |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Avinash R. Tekadea |
| 773 0# - HOST ITEM ENTRY | |
| Host Biblionumber | 125265 |
| Host Itemnumber | 113416 |
| Place, publisher, and date of publication | Mumbai Indian Drugs Manufacturer's Association |
| Title | Indian Drugs |
| International Standard Serial Number | 0019-462X |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Koha item type | Journal Article |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Location (home branch) | Sublocation or collection (holding branch) | Date acquired | Koha issues (times borrowed) | Piece designation (barcode) | Koha date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | SNDT Juhu | SNDT Juhu | 21/08/2025 | jp839.4 | 21/08/2025 | 21/08/2025 | Journal Article |