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_aAIKTC-KRRC _cAIKTC-KRRC |
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_916074 _aVanavi, Pragati J. |
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245 | _aImpurity profiling of first line anti-tb drug-terizidone using chromatographic and related techniques | ||
250 | _aVol.13(5) | ||
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_aM P _bInnovare Academic Sciences Pvt Ltd _c2021 |
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300 | _a83-95p. | ||
520 | _aObjective: 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 |
_94639 _aPHARMACEUTICS |
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_916075 _aRajput, Sadhana J. |
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773 | 0 |
_x2656-0097 _tInternational journal of pharmacy and pharmaceutical science _dBhopal Innovare Academic Sciences Pvt Ltd |
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_uhttps://innovareacademics.in/journals/index.php/ijpps/article/view/40918/24716 _yClick here |
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_2ddc _cAR |