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_c23433 _d23433 |
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| 003 | OSt | ||
| 005 | 20250919160402.0 | ||
| 008 | 250919b xxu||||| |||| 00| 0 eng d | ||
| 040 |
_aAIKTC-KRRC _cAIKTC-KRRC |
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| 100 |
_927231 _aRathore, Manoj Kumar |
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| 245 | _aTandem mass spectrometric method for the trace level determination of 2-aminopyridine: a potential genotoxic impurity in tenoxicam API | ||
| 250 | _aVol.16(4) | ||
| 260 |
_aBhopal _bInnovare Academic Sciences Pvt Ltd _c2024 |
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| 300 | _a50-56p. | ||
| 520 | _aObjective: This study aimed to develop a highly sensitive method for the determination of the genotoxic impurity 2-amino pyridine in Tenoxicam, employing hyphenated techniques. Methods: The determination of 2-amino pyridine was carried out using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method in Selected Ion Monitoring mode (SIM). A LiChrospher RP-18 (100×4.6 mm) 5.0 µm column was utilized for the separation. A gradient elution technique was employed with acetonitrile (mobile phase A) and 0.01M ammonium acetate buffer (mobile phase B) in varying ratios. The gradient program (T/%B) was set as 0/5, 2.50/15, 5.00/30, 10.00/50, 15.00/95, 20.00/95. The developed method was validated according to the International Conference on Harmonization guidelines. Results: The limits of detection (LOD) and quantification (LOQ) for 2-amino pyridine were found to be 0.09 ppm and 0.3 ppm, respectively. The method demonstrated accuracy within the range of 89.1% to 106.6% for the analyte. The method's linearity was confirmed through a six-point calibration graph spanning 6 ppm to 75 ppm, corresponding to a concentration of 20 mg/ml of Tenoxicam. Conclusion: Developed hyphenated LC-MS/MS method presented in this study offers a highly sensitive and accurate means for the determination of the genotoxic impurity 2-amino pyridine in Tenoxicam. With validated LOD and LOQ values, as well as demonstrated accuracy, this method proves to be a robust quality control tool suitable for the quantitation of 2-amino pyridine at very low concentrations in the pharmaceutical compound Tenoxicam. | ||
| 650 | 0 |
_94639 _aPHARMACEUTICS |
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| 700 |
_927232 _aReddy, T. Rama Mohan |
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| 773 | 0 |
_dBhopal Innovare Academic Sciences Pvt Ltd _x2656-0097 _tInternational journal of pharmacy and pharmaceutical science |
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| 856 |
_uhttps://journals.innovareacademics.in/index.php/ijpps/article/view/49902 _yClick here |
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| 942 |
_2ddc _cAR |
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