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Pharmaceutical Applications Notebook

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Pharmaceutical Applications Notebook Pharmaceutical Applications Notebook Antibiotics Table of Contents Index of Analytes .......................................................................................................................................................................3 Introduction to Pharmaceuticals ................................................................................................................................................4 UltiMate 3000 UHPLC+ Systems .............................................................................................................................................5 IC and RFIC Systems ................................................................................................................................................................6 MS Instruments .........................................................................................................................................................................7 Chromeleon 7 Chromatography Data System Software ..........................................................................................................8 Process Analytical Systems and Software ................................................................................................................................9 Automated Sample Preparation ..............................................................................................................................................10 Analysis of Antibiotics ...........................................................................................................................................................11 Determination of Tobramycin and Impurities Using HPAE-IPAD ........................................................................................12 Determination of Neomycin B and Impurities Using HPAE-IPAD .......................................................................................24 Determination of Sulfur-Containing Antibiotics Using Integrated Pulsed Amperometric Detection (IPAD) ......................38 Determination of Streptomycin and Impurities Using HPAE-PAD .......................................................................................50 Analysis of Paromomycin by HPAE-IPAD ............................................................................................................................64 Determination of Sulfate Counter Ion and Aionic Impurities in Aminoglycoside Drug Substances by Ion Chromatography with Suppressed Conductivity Detection ................................................................................72 Determination of N-Methylpyrrolidine in Cefepime Using a Reagent-Free Ion Chromatography System .........................82 Determination of Cefepime and Cefepime-Related Substances Using HPLC with UV Detection ......................................90 Sulfonamide Antibiotics on Acclaim 120 C18 RSLC ............................................................................................................98 Rapid HPLC Separation of Multiclass Antibiotics in Food and Water ..................................................................................99 Determination of N-Methylpyrrolidine in Cefepime with Nonsuppressed Conductivity Detection ..................................101 Determination of 2-Ethylhexanoic Acid Impurity in Clavulanate .......................................................................................107 Analysis of the Aminoglycoside Antibiotics Kanamycin and Amikacin Matches USP Requirements ..............................113 New HPLC and UHPLC Assay Methods for Tetracycline Hydrochloride and 4-Epianhydrotetracycline Hydrochloride Impurity in Tetracycline Drug Products ................................................................................................119 Determination of Tobramycin in Crude and In-Process Production Samples During Manufacturing Using HPAE-IPAD .........................................................................................................................................................126 Column Selection Guide .....................................................................................................................................................132 Thermo Scientific Acclaim Column Selection Guide ..........................................................................................................133 Transferring HPLC Methods to UHPLC .........................................................................................................................134 Easy Method Transfer from HPLC to RSLC with the Dionex Method Speed-Up Calculator ...........................................135 Index of Analytes 2-Deoxy-streptamine .....................................................................126 Neomycin B ...............................................................................24, 72 2-Ethylhexanoic acid .....................................................................107 Nebramine .....................................................................................126 4-Epianhydrotetracycline hydrochloride ...................................... 119 Neomycin.......................................................................................126 Acetate .............................................................................................72 Nitrofurantoin ..................................................................................99 Amikacin ................................................................................. 72, 113 N-Methylpyrrolidine ................................................................82, 101 Ampicillin ........................................................................................38 Oxytetracycline ................................................................................99 Anions ..............................................................................................72 Paromomycin .............................................................................64, 72 Arginine .........................................................................................101 Pyrophosphate .................................................................................72 Cephapirin .......................................................................................38 Sisomicin .........................................................................................72 Cephradine .......................................................................................38 Streptomycin A ..........................................................................50, 72 Cefepime ............................................................................82, 90, 101 Sulfamethoxazole ......................................................................38, 90 Chloramphenicol .............................................................................99 Sulfanilimide .............................................................................38, 90 Clavulante ......................................................................................107 Sulfathiazole ....................................................................................99 Deoxystreptamine-kanosaminide ..................................................126 Tetracycline.............................................................................. 99, 119 Dihydrostreptomycin .................................................................50, 72 Tobramycin ..............................................................................12, 126 Kanamycin .................................................................12, 72, 113, 126 Trimethoprim ...................................................................................38 Lincomycin ......................................................................................38 Tylosin .............................................................................................99 Neamine .....................................................................................12, 24 Index of Analytes 3 Introduction to Pharmaceuticals The pharmaceutical industry is the largest consumer Although, some of the applications published in of high-performance liquid chromatography (HPLC) this notebook were created some time ago, they are instrumentation. In drug discovery, HPLC and ion still relevant today. In the event that specific models chromatography (IC) systems are used both as stand- of systems or modules used in these applications are alone tools and as front ends for mass spectrometers to no longer available, their methods may still be used on screen drug candidates. In pre-clinical development, they current instrumentation with similar performance. are used for analyzing in-vitro and in-vivo samples. In Thermo Scientific and Dionex Integrated Systems clinical trials, they are used to gather data on a potential drug’s safety and efficacy. They are used in manufacturing Dionex Products are now a part of the Thermo for many tasks including quality assurance/quality control Scientific brand, creating exciting new possibilities for (QA/QC), and the validation of cleaning procedures. scientific analysis. Now, leading capabilities in liquid This applications notebook has been compiled to chromatography (LC), IC, and sample preparation are help the pharmaceutical scientist by providing a together in one portfolio with those in mass spectrometry wide range of application examples relevant to the
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