Impurities test for Sulfadiazine (EP-8.0 method)
Applications | | Thermo Fisher ScientificInstrumentation
Impurity profiling in sulfadiazine is essential to maintain drug quality and comply with regulatory standards. Routine testing prevents adverse effects and ensures batch consistency.
This work outlines the European Pharmacopoeia version 8.0 method for detecting and separating specified impurities in sulfadiazine. The study demonstrates sample preparation, reference solutions, chromatographic settings, and system suitability assessment.
Sample preparation involves dissolving sulfadiazine in a sodium hydroxide, acetonitrile and water mixture, with multiple reference solutions for impurities A, B, and E. Chromatographic separation uses an UltiMate 3000 liquid chromatograph with an Acclaim Polar Advantage II C18 column under isocratic conditions (acetonitrile and phosphoric acid solution 10:90), at 25 degrees Celsius, 1.2 mL per minute flow, 20 microliter injections, and UV detection at 260 nm over a 35 minute run time.
System suitability tests meet European Pharmacopoeia criteria. The resolution between Impurity A and B exceeds the minimum requirement (2.8 vs 2.0), and the sulfadiazine peak exhibits a tailing factor well below 2.0 (0.8). Chromatograms confirm clear separation of target analytes and reference impurities.
The validated method provides a robust and reproducible approach for quality control laboratories. Its straightforward sample preparation and compliance with pharmacopoeial standards make it suitable for routine batch release testing.
Potential improvements include gradient elution to reduce analysis time, coupling with mass spectrometry for enhanced sensitivity, and adapting the method for related sulfonamide compounds in high-throughput settings.
The EP 8.0 method for sulfadiazine impurity testing delivers reliable separation and quantification, ensuring regulatory compliance and supporting pharmaceutical quality assurance.
European Pharmacopoeia version 8.0, Monograph for Sulfadiazine impurity testing
HPLC
IndustriesPharma & Biopharma
ManufacturerThermo Fisher Scientific
Summary
Importance of the Topic
Impurity profiling in sulfadiazine is essential to maintain drug quality and comply with regulatory standards. Routine testing prevents adverse effects and ensures batch consistency.
Objectives and Study Overview
This work outlines the European Pharmacopoeia version 8.0 method for detecting and separating specified impurities in sulfadiazine. The study demonstrates sample preparation, reference solutions, chromatographic settings, and system suitability assessment.
Methodology and Instrumentation
Sample preparation involves dissolving sulfadiazine in a sodium hydroxide, acetonitrile and water mixture, with multiple reference solutions for impurities A, B, and E. Chromatographic separation uses an UltiMate 3000 liquid chromatograph with an Acclaim Polar Advantage II C18 column under isocratic conditions (acetonitrile and phosphoric acid solution 10:90), at 25 degrees Celsius, 1.2 mL per minute flow, 20 microliter injections, and UV detection at 260 nm over a 35 minute run time.
Used Instrumentation
- UltiMate 3000 LC system
- Acclaim Polar Advantage II C18 column (4.6 x 250 mm, 5 um)
Main Results and Discussion
System suitability tests meet European Pharmacopoeia criteria. The resolution between Impurity A and B exceeds the minimum requirement (2.8 vs 2.0), and the sulfadiazine peak exhibits a tailing factor well below 2.0 (0.8). Chromatograms confirm clear separation of target analytes and reference impurities.
Benefits and Practical Applications
The validated method provides a robust and reproducible approach for quality control laboratories. Its straightforward sample preparation and compliance with pharmacopoeial standards make it suitable for routine batch release testing.
Future Trends and Opportunities
Potential improvements include gradient elution to reduce analysis time, coupling with mass spectrometry for enhanced sensitivity, and adapting the method for related sulfonamide compounds in high-throughput settings.
Conclusion
The EP 8.0 method for sulfadiazine impurity testing delivers reliable separation and quantification, ensuring regulatory compliance and supporting pharmaceutical quality assurance.
Reference
European Pharmacopoeia version 8.0, Monograph for Sulfadiazine impurity testing
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