HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient (Record no. 17630)
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| 000 -LEADER | |
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| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20220923144946.0 |
| 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) | 18080 |
| Author | Bharti, Amber |
| 245 ## - TITLE STATEMENT | |
| Title | HPLC method development and validation for the quantification of related impurities in testosterone cypionate active pharmaceutical ingredient |
| 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 | 240-246p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Aim: The purpose of this research study, is to develop and validate a reverse phase HPLC<br/>test method for detecting relevant impurities in Testosterone cypionate (TCY). Materials<br/>and Methods: The chromatographic system for separation of related impurities were<br/>achieved in Zorbax XDB-C8 (15 cm x 4.6 mm), 5 micron HPLC column utilising gradient<br/>elution technique. Water was selected as solvent-A and Acetonitrile was preferred as<br/>solvent-B for mobile phase. The method is gradient technique. Column heater was kept<br/>constant at 35°C; the rate of flow was 1.2 mL per min; volume of injection was 20 μL<br/>and 240 nm was set for detector wavelength. Results: The % recovery was in the range<br/>of 95.6% to 108.7% for all impurities. The result of correlation coefficient were higher<br/>than 0.98. Testosterone is the major degradants obtained from forced degradation study.<br/>Conclusion: The created method can be utilise in quality control testing on a regular basis<br/>for the analysis of Testosterone cypionate. |
| 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) | 18081 |
| Co-Author | Kumbhare, Ravindra Motiram |
| 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-56-1-240.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 | 2022-1722 | 23/09/2022 | 23/09/2022 | Articles Abstract Database |