| 000 -LEADER |
|---|
| fixed length control field |
a |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20181204152752.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| 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 |
|
| Koha item type |
Articles Abstract Database |
