Spectroscopic substantiation for the identification of degradants by Q-TOF micromass (ESI-MS) in bisoprolol fumarate with an inventive validation approach for stability indicating HPLC method (Record no. 17639)
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| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220923153108.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220923b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14964 |
| Author | Pandey, Swati |
| 245 ## - TITLE STATEMENT | |
| Title | Spectroscopic substantiation for the identification of degradants by Q-TOF micromass (ESI-MS) in bisoprolol fumarate with an inventive validation approach for stability indicating HPLC method |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.56(1), Jan-Mar |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Karnataka |
| Name of publisher, distributor, etc. | Association of Pharmaceutical Teachers of India (APTI) |
| Year | 2022 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 272-280p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Background: Stability studies, stress testing of drug substances and finished drug<br/>product is obligatory due to the guidelines by the International Council for Harmonisation<br/>of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other<br/>Regulatory Authorities. Materials and Methods: In the present work the selective Beta-1<br/>receptor blocker, Bisoprolol fumarate was subjected to the forced degradation studies<br/>which includes hydrolysis (acidic, basic and neutral), oxidative, photolytic and thermal<br/>degradation. The drug was stable under light and basic and neutral medium. Results: The<br/>major findings in the presented work are the degradation products formed in the course<br/>of thermal degradation. The complete thermal degradation products were identified<br/>by High Performance Liquid Chromatography, Quadrupole-Time of Flight micromass<br/>(Electronspray Ionization-Mass Spectroscopy). The chromatographic conditions opted for<br/>the study includes Cosmosil C -18 column (4.6ID*250mm) with mobile phase consisting<br/>of methanol: phosphate buffer (pH 3.5 adjusted with orthophosphoric acid): Acetonitrile<br/>(45:35:20). Conclusion: The stability indicating method was validated as per the<br/>International Conference on Harmonization guidelines. The use of superior statistical<br/>tools for validation ensures the efficiency, quality and reproducibility of the presented<br/>method. Results obtained were agreeable and ensured the quality and reproducibility of<br/>the method. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 14966 |
| Co-Author | Pandey, Ravindra |
| 773 0# - HOST ITEM ENTRY | |
| Title | Indian journal of pharmaceutical education and research |
| Place, publisher, and date of publication | Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| International Standard Serial Number | 0019-5464 |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-1-272.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dewey Decimal Classification | School of Pharmacy | School of Pharmacy | Archieval Section | 23/09/2022 | 2022-1726 | 23/09/2022 | 23/09/2022 | Articles Abstract Database |