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a |
| 003 - CONTROL NUMBER IDENTIFIER |
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OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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20220211113047.0 |
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220211b xxu||||| |||| 00| 0 eng d |
| 040 ## - CATALOGING SOURCE |
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AIKTC-KRRC |
| Transcribing agency |
AIKTC-KRRC |
| 100 ## - MAIN ENTRY--PERSONAL NAME |
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| 9 (RLIN) |
16074 |
| Author |
Vanavi, Pragati J. |
| 245 ## - TITLE STATEMENT |
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| Title |
Impurity profiling of first line anti-tb drug-terizidone using chromatographic and related techniques |
| 250 ## - EDITION STATEMENT |
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| Volume, Issue number |
Vol.13(5) |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Place of publication, distribution, etc. |
M P |
| Name of publisher, distributor, etc. |
Innovare Academic Sciences Pvt Ltd |
| Year |
2021 |
| 300 ## - PHYSICAL DESCRIPTION |
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| Pagination |
83-95p. |
| 520 ## - SUMMARY, ETC. |
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| Summary, etc. |
Objective: The objective of the present study was to investigate the stability of TRZ against different stressors and to prepare impurity profile for potential impurities and degradation products (DPs) formed under stress degradation of TRZ bulk drug and formulation.Methods: Three analytical methods were developed; the stability-indicating method that was developed using HPLC instrument with 0.01M ammonium acetate buffer (pH 4.0 using glacial acetic acid (GAA)) and acetonitrile in gradient program. The second method was a UPLC/ESI-MS method using 0.1 % Formic acid in Milli Q water (pH= 2.70) and 0.1%Formic acid in Milli Q water: Acetonitrile (10:90) in gradient program foridentification of TRZ and DPs while the third, preparative HPLC method was used for isolation of impurities using (A) 0.05% ammonia (NH3Results: The analytical method for stability study was developed and validated using ICH (Q2) R1 guidelines. The result of stability study by stress degradation showed that TRZ was susceptible to degradation in acid (7 DPs), alkaline, neutral (9 DPs) and oxidative conditions (10 DPs); major DPs were identified (where it was possible) and the chemical structure was elucidated by combining the data of ESI/MS, NMR and/or Tandem MS. The Impurity profiling was completed by reporting all the DPs, either major or minor for TRZ bulk drug and formulation. ) in water and (B) Acetonitrile+20% mobile phase A in gradient sequence. Gradient sequences are described in the main text. Conclusion: The complete Impurity profiling for TRZ is reported for the first time in literature. The study data would be add-on for formulation storage condition and further development. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| 9 (RLIN) |
4639 |
| Topical term or geographic name entry element |
PHARMACEUTICS |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| 9 (RLIN) |
16075 |
| Co-Author |
Rajput, Sadhana J. |
| 773 0# - HOST ITEM ENTRY |
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| International Standard Serial Number |
2656-0097 |
| Title |
International journal of pharmacy and pharmaceutical science |
| Place, publisher, and date of publication |
Bhopal Innovare Academic Sciences Pvt Ltd |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| URL |
https://innovareacademics.in/journals/index.php/ijpps/article/view/40918/24716 |
| Link text |
Click here |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Source of classification or shelving scheme |
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| Koha item type |
Articles Abstract Database |
