pharmaceutical impurity analysis solutions - Lcms-connect.com

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3.1ANALYSIS OF ORGANIC IMPURITIESAchieve precision, linearity,sensitivity, and speed inimpurity analysis with theAgilent 1200 Infinity Series LCAgilent 1200 Infi nity Series LC/UV Systems are an ideal solution for impurity analysis inpharmaceutical quality control laboratories seeking to achieve the necessary precision,linearity, sensitivity, and speed required to meet the regulatory standards for impurityanalysis. The example shown in Figure 6 is for the analysis of amoxicillin and itsimpurities. This analysis was completed within 7 minutes and detected impurities downto a level of 0.01 %. Excellent precision of retention times, peak areas, and linearitywas achieved with a correlation coeffi cient of R 2 > 0.999 (Figure 7) for fi ve impurities.mAU8Impurity AAmoxicillin642Impurity CImpurity BImpurity DImpurity E00 0.5 1 1.5 2 2.5 3 3.5 4 4.5 minFigure 6. Analysis of amoxicillin and five impurities using the Agilent 1220 Infinity LC System and a gradientmethod in combination with UV detection, an Agilent ZORBAX SB-Aq column, and ChemStation software.See Agilent publication 5990-6093EN.Area10864200Impurity ACorrelation: 0.999992.5 5 7.5Amount (ng/μL)Area32.521.510.50Impurity BCorrelation: 0.999620 2.5 5 7.5Amount (ng/μL)Area21.751.51.2510.750.50.250Impurity CCorrelation: 0.999870 5 10Amount (ng/μL)Impurity DArea Correlation: 0.9999821.510.500 2 4Amount (ng/μL)Area543210Impurity ECorrelation: 0.999870 2 4 5Amount (ng/μL)Figure 7. The impurities in amoxicillin are measured with excellent linearity at six concentration levels.See Agilent publication 5990-6093EN.16
Agilent’s UHPLC/UV solutions help achieve higher sensitivity, faster sample throughput,and signifi cant cost savings in impurity profi ling. Since the 1290 Infi nity LC can beoperated at up to 1200 bar pressure, using a very sensitive DAD detector, signifi cantlyfaster methods can be developed for profi ling impurities in a highly productive manner.This leads to a signifi cant reduction in the cost per analysis.The Agilent Multi-Method solution for LC is ideally suited for testing experimentalconditions, such as determining the ideal combination of stationary and mobilephases. It makes scouting stationary and mobile phases a simple, automated task,especially when short run times are used (e.g., a few minutes on an Agilent 1260 or1290 Infi nity LC).The Agilent Intelligent System Emulation Technology (ISET) can be used when there isa need to transfer the fi nal method optimized on UHPLC to standard HPLC equipmentand columns, especially in regulated QA/QC environments. ISET can be used toexecute new or legacy HPLC methods, delivering the same chromatographic resultswithout the need to change the original method or modify the instrument hardware.Other HPLC orUHPLC System1100 Series LC1200 Series LC1290 Infinity LCwith ISETMethod Transfer1220 Infinity LC 1260 Infinity LCFigure 8. Agilent’s ISET system can be used to efficiently transfer methods from a range ofsystems to the final QC environment. See Agilent publication 5990-8670EN.17
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