HPLC Determination of n-methylethanolamine in diphenhydramine hydrochloride drug substance by pre- (Record no. 7760)
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| 000 -LEADER | |
|---|---|
| fixed length control field | a |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20181204152752.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 181204b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | AIKTC-KRRC |
| Transcribing agency | AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 6559 |
| Author | Anerao, A. |
| 245 ## - TITLE STATEMENT | |
| Title | HPLC Determination of n-methylethanolamine in diphenhydramine hydrochloride drug substance by pre- |
| 250 ## - EDITION STATEMENT | |
| Volume, Issue number | Vol. 55 (10) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Mumbai |
| Name of publisher, distributor, etc. | Indian Drug Manufacture's Association - IDMA |
| Year | 2018 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Pagination | 56-62 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | N-Methylethanolamine is the side chain of the drug diphenhydramine hydrochloride. A sensitive high performance liquid chromatography method with pre-column derivatization was developed and validated for the determination of N-methylethanolamine impurity in diphenhydramine hydrochloride active pharmaceutical ingredient. HPLC method on column Cosmosil MS-II, C-18, 250 mm X 4.6 mm, particle size 5 μm with UV detector was used. The proposed method is specific, linear, accurate, rugged and precise. The calibration curves showed good linearity over the concentration range of 0.03 mg/g to 1.5 mg/g and the correlation coefficient was 0.999. Method had very low limit of detection (LOD) and limit of quantification (LOQ) as 0.01 mg/g and 0.03 mg/g, respectively, of the analyte. Accuracy was observed within 94.4% to 96.2%. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 4639 |
| Topical term or geographic name entry element | PHARMACEUTICS |
| 653 ## - Keywords | |
| Keywords | Derivatization |
| -- | validation |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 6561 |
| Co-Author | Dighe, V. |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 6562 |
| Co-Author | Gupta, A. |
| 773 0# - HOST ITEM ENTRY | |
| Title | Indian drugs |
| Place, publisher, and date of publication | Mumbai Indian Drug Manufactures Association |
| 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 | 28/03/2019 | 2018008 | 19/06/2019 | 28/03/2019 | Articles Abstract Database |