Impurity profiling of first line anti-tb drug-terizidone using chromatographic and related techniques
By: Vanavi, Pragati J
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Contributor(s): Rajput, Sadhana J.
Publisher: M P Innovare Academic Sciences Pvt Ltd 2021Edition: Vol.13(5).Description: 83-95p.Subject(s): PHARMACEUTICSOnline resources: Click here
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International journal of pharmacy and pharmaceutical scienceSummary: 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.
| Item type | Current location | Call number | Status | Date due | Barcode | Item holds |
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Articles Abstract Database
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School of Pharmacy Archieval Section | Not for loan | 2022-0489 |
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.
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