Forced degradation of flibanserin bulk drug: Development and validation of stability indicating RP-HPLC method (Record no. 17593)
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| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220922110822.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220922b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 18022 |
| Author | Chew, Yik-Ling |
| 245 ## - TITLE STATEMENT | |
| Title | Forced degradation of flibanserin bulk drug: Development and validation of stability indicating RP-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 | 32-42p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Background: Flibanserin had been approved as the first drug by United State Food and<br/>Drug Administration (USFDA) for the treatment of female sexual interest/arousal disorder<br/>of any severity. However, the stability of this drug has yet to be studied extensively.<br/>Objectives: The objectives of this study were to optimize the stability indicating method<br/>and evaluate the stability of flibanserin under various forced degradation conditions,<br/>determine the order of the degradation kinetics, half-life and shelf life of flibanserin under<br/>certain stress conditions. The stability of flibanserin under various stress conditions which<br/>would reflect the important aspects of storage condition and excipients which should be<br/>avoided in the formulation of this drug substance into final drug products. Methods:<br/>Stability indicating method was developed using HPLC. It was validated according to<br/>ICH guideline for its linearity, precision, accuracy, robustness, LOD and LOQ. The forced<br/>degradation was performed under various stress conditions, namely acidic, alkaline and<br/>oxidative conditions (H2O2, AIBN and FeCl3). LC-MS was utilised for identification of the<br/>degradation impurities, and the degradation kinetics was evaluated based on the kinetic<br/>models. Results: Degradation of flibanserin was noticed under oxidative conditions.<br/>Flibanserin was degraded under H2O2 oxidation at room temperature, while AIBN and<br/>FeCl3 at elevated temperature. Two N-oxide impurities were identified under H2O2<br/>oxidation. Flibanserin was degraded following the first-order kinetic under H2O2 and AIBN<br/>oxidation, while zero-order under FeCl3 oxidation. Half-life and shelf life of flibanserin<br/>under respective stress conditions were determined. Conclusion: It is concluded that<br/>the RP-HPLC method developed could be used as the stability indicating method in<br/>determination of flibanserin stability and its impurities. Flibanserin is sensitive towards<br/>oxidative degradation. The impurities and the order of the degradation kinetics were identified. |
| 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) | 18023 |
| Co-Author | Lee, Hon-Kent |
| 773 0# - HOST ITEM ENTRY | |
| Place, publisher, and date of publication | Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| International Standard Serial Number | 0019-5464 |
| Title | Indian journal of pharmaceutical education and research |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-1-32.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 | 22/09/2022 | 2022-1695 | 22/09/2022 | 22/09/2022 | Articles Abstract Database |