Gradient RP-HPLC method for the determination of potential impurities in atazanavir sulfate

This paper proposes a simple and selective RP-HPLC method for the determination of process impurities and degradation products (degradants) of atazanavir sulfate (ATV) drug substance. Chromatographic separation was achieved on Ascentis ® Express C8, (150 mm × 4.6 mm, 2.7 μm) column thermostated at 3...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2011-04, Vol.55 (1), p.31-47
Hauptverfasser:	Chitturi, Sreenivasa Rao, Somannavar, Yallappa Somappa, Peruri, Badarinadh Gupta, Nallapati, Sreenivas, Sharma, Hemant Kumar, Budidet, Shankar Reddy, Handa, Vijay Kumar, Vurimindi, Hima Bindu
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Analytical, structural and metabolic biochemistry Atazanavir Sulfate Biological and medical sciences Chromatography, High Pressure Liquid Drug Contamination Drug Stability drugs Fourier transform infrared spectroscopy Fundamental and applied biological sciences. Psychology General pharmacology HIV Protease Inhibitors - chemistry humidity Hydrogen-Ion Concentration Isolation and characterization Kinetics Limit of Detection Magnetic Resonance Spectroscopy Medical sciences Method development and validation Molecular Structure nuclear magnetic resonance spectroscopy Oligopeptides - chemistry Order of reaction Pharmacology. Drug treatments potassium dihydrogen phosphate Potential impurities Pyridines - chemistry Quality Control Reproducibility of Results reversed-phase high performance liquid chromatography spectral analysis Spectrometry, Mass, Electrospray Ionization Spectroscopy, Fourier Transform Infrared Tandem Mass Spectrometry Technology, Pharmaceutical
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