Chemometric Assisted Development and Validation of a Stability-indicating LC Method for Determination of Related Substances in Haloperidol Decanoate Injection (Record no. 15544)
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| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20211122152913.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211122b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 9942 |
| Author | Kolla, Sudheer Babu |
| 245 ## - TITLE STATEMENT | |
| Title | Chemometric Assisted Development and Validation of a Stability-indicating LC Method for Determination of Related Substances in Haloperidol Decanoate Injection |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol.55(3), Jul-Sep |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Banagalore |
| Name of publisher, distributor, etc. | Association of Pharmaceutical Teachers of India (APTI) |
| Year | 2021 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 904-915p. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Aim: Haloperidol decanoate injection is a phenyl butyl piperadine derivative with antipsychotic, neuroleptic, antiemetic effects and has multiple related substances as process and degradant impurities. Objectives: This study focuses on chemometric assisted liquid chromatographic approach to develop a stability indicating impurity profile of Haloperidol decanoate injection. Methodology: Dual experimental designs (combined mixture I-optimal design and response surface historical data design) were employed to resolve all thirteen known impurities of Haloperidol decanoate. Chromatographic separation was achieved on a Hypersil BDS C18 (100 x 4.0 mm) 3-μm column to attain separation of related compounds. Results: The optimum conditions for the chromatographic system resulted in a mobile phase consisting of tetra butyl ammonium hydrogen sulphate/ 1-decane Sulphonate sodium buffer solution and acetonitrile with linear gradient elution at a flow rate of 1.4 mL/min. Selectivity, forced degradation, linearity, accuracy and precision were demonstrated in a range of 0.75-30.0 μg/mL. Conclusion: The optimized method was able to resolve the ghost peak observed because of gradient change of mobile phase and is able to separate both polar and non-polar impurities within 60 min, in single method, with resolution of more than 2.0 between adjacent impurities. The inter-day precision for all impurities and haloperidol decanoate were evaluated and found to have a % RSD of less than 10. |
| 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) | 9943 |
| Co-Author | Vallabhaneni, Madhusudhan Rao |
| 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-55-3-904.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 | 22/11/2021 | 2021-2022349 | 22/11/2021 | 22/11/2021 | Articles Abstract Database |