The determination of drug tablet concentration in pharmaceutical applications for drug development using the Agilent Cary 60 UV-Vis with fiber optics

Importance of the Topic

Dissolution analysis of solid dosage forms is critical to ensure consistent release of active pharmaceutical ingredients. In situ ultraviolet-visible spectrophotometry using fiber optics enables real time monitoring of dissolution profiles, improving process insight and speeding decision making in drug development and manufacturing.

Objectives and Study Overview

This application demonstrates the use of an Agilent Cary 60 UV-Vis spectrophotometer with fiber optic probe to determine the concentration of an antimalarial active ingredient during tablet dissolution. The goal was to assess linearity, reproducibility, and potential time and cost savings of in situ measurements compared to traditional offline sampling.

Methodology

• Calibration performed with six standard solutions of the antimalarial compound in isopropanol over a 0 to 300 mg/L range.
• Dissolution bath simulated gastrointestinal conditions with the fiber optic probe immersed directly in the medium.
• Absorbance data recorded via WinUV software concentration module to generate a calibration curve for real time analysis.

Instrumentation Used

• Agilent Cary 60 UV-Vis Spectrophotometer with PC and WinUV software (21 CFR part 11 compliant)
• Torlon fiber optic probe and coupler
• Dissolution bath configured for physiological agitation

Main Results and Discussion

Calibration demonstrated exceptional linearity (correlation coefficient 0.9998) over absorbance values up to two absorbance units. Triplicate measurements of unknown tablet samples yielded a mean concentration of 281.4 mg/L with relative standard deviation below 0.3%, highlighting the method’s reliability. Real time monitoring eliminated sample handling delays and maintained data integrity for precise API quantification.

Benefits and Practical Applications

• Reduced analysis time by avoiding offline sample preparation and transfer
• Enhanced throughput for small batch testing without requiring large automated systems
• Regulatory compliance supported by integrated 21 CFR part 11 software capabilities
• Potential integration into process analytical technology workflows for continuous monitoring

Future Trends and Opportunities

Automated fiber optic dissolution systems will support higher sample volumes and unattended operation. Advances in software analytics and integration with manufacturing execution systems can further streamline quality control. Emerging compact probes and wireless optical sensors may expand real time analysis to diverse formulations and production scales.

Conclusion

In situ UV-Vis measurements with fiber optics provide a robust and efficient approach for dissolution testing of pharmaceutical tablets. The Agilent Cary 60 platform delivers high linearity and reproducibility, driving time and cost savings while maintaining regulatory compliance. This method offers a valuable tool for drug development and quality control laboratories.

Reference

1. British Pharmacopoeia 2011 online; British Pharmacopoeia Volume III; Formulated Preparations: Specific Monographs