Design of experiment mediated development of stability indicating high performance thin layer chromatography method invoking failure mode effect analysis based risk assessment in estimation of edoxaban tosylate monohydrate (Record no. 17375)
[ view plain ]
| 000 -LEADER | |
|---|---|
| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220901100252.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 220901b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 17682 |
| Author | Mistry, Vrunda Balvantbhai |
| 245 ## - TITLE STATEMENT | |
| Title | Design of experiment mediated development of stability indicating high performance thin layer chromatography method invoking failure mode effect analysis based risk assessment in estimation of edoxaban tosylate monohydrate |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.56(2), Apr-June |
| 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 | 553-563p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Aim: Development of stability indicating high performance thin layer chromatographic method for quantification of edoxaban tosylate monohydrate in its pharmaceutical dosage form using quality by design approach. Methods: Degradation was performed in acidic, alkaline, neutral, oxidative and photolytic conditions. Analytical target profile was identified, based on which failure modes were identified by brainstorming session and preliminary trials. Each failure mode was assigned a risk priority number based on its severity and detectability. Identified potential method variables were further screened by Taguchi OA design. 32 full factorial design was applied for optimization of critical factors. The developed analytical method was validated using the Q2R1 guideline of the International Council for Harmonization. Results: In acidic, alkaline, and oxidative environments, the substance was shown to be degraded. After failure mode analysis, seven factors were found potential for estimation as it shows high risk priority number (RPN). Two important method variables, the volume of modifier and migration distance, were screened using screening design from these seven components. For the estimation of edoxaban tosylate monohydrate, the response surface model created design space and a control strategy was devised. Method found to be accurate, precise, and linear, with detection limit 1.021 ng/band and quantification limit 3.095 ng/band. Conclusion: Using methanol-ethyl acetate-triethylamine (6:4:0.2, v/v) as mobile phase on silica gel GF254 plate, described method was effectively employed for estimation of edoxaban tosylate monohydrate in its tablet dosage form. |
| 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) | 17683 |
| Co-Author | Patel, Hitika Bharatbhai |
| 773 0# - HOST ITEM ENTRY | |
| International Standard Serial Number | 0019-5464 |
| Title | Indian journal of pharmaceutical education and research |
| Place, publisher, and date of publication | Bengluru Association of Pharmaceutical Teachers of India (APTI) |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| URL | https://www.ijper.org/sites/default/files/IndJPhaEdRes-56-2-553.pdf |
| Link text | Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | |
| Koha item type | Articles Abstract Database |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Permanent Location | Current Location | Shelving location | Date acquired | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| School of Pharmacy | School of Pharmacy | Archieval Section | 2022-09-01 | 2022-1448 | 2022-09-01 | 2022-09-01 | Articles Abstract Database |