Agilent Online UV-Vis Dissolution Systems

Importance of the Topic

The automated online analysis of dissolution using UV-Vis spectrophotometry plays a critical role in pharmaceutical development and quality control. It enables real-time monitoring of drug release, ensures compliance with regulatory standards, and reduces manual intervention and potential for error. Enhanced throughput and data reliability support formulation optimization and batch release testing.

Objectives and Overview of the Article

This article presents Agilent’s portfolio of online UV-Vis dissolution solutions centered around the Cary 60 spectrophotometer. It compares multicell and fiber optic configurations, outlines system components and software integration, and highlights performance specifications that meet pharmacopeial requirements.

Methodology and Instrumentation

The systems operate in two primary modes:

• Multicell UV dissolution: Individual flow cells for each vessel, sample transfer via peristaltic pump or 850-DS station, optional offline HPLC archiving.
• Fiber optic dissolution: In situ sampling with movable probe manifold, rapid multiplexed readings, minimal hydrodynamic disturbance.

The Cary 60 spectrophotometer offers a scanning optical design with a xenon flash lamp, a 190–1100 nm wavelength range, and photometric accuracy of ±0.005 Abs.

Used Instrumentation

• Cary 60 UV-Vis Spectrophotometer
• Multicell changer or rotary fiber optic multiplexer
• 850-DS Dissolution Sampling Station (optional)
• Cary WinUV and Dissolution Software with 21 CFR Part 11 compliance (SCM/SDA)

Key Results and Discussion

Performance evaluations demonstrate:

• Linear photometric range above 3.5 Abs with R² of 0.999 at 525 nm.
• Lamp lifetime of up to 10 years under normal use, zero warm-up time, and low photodegradation risk.
• Sampling intervals as short as 45 seconds in fiber optic mode and simultaneous sampling in multicell mode.

These features ensure accurate, reproducible dissolution profiles and seamless data acquisition.

Benefits and Practical Applications

The integrated systems offer:

• Automated sampling and dosage delivery to improve workflow efficiency.
• Elimination of cross-contamination through individual flow paths.
• In situ analysis for formulations with excipient interference.
• Customizable software reporting and 21 CFR Part 11 compliance for regulated environments.

Applications include routine QC, formulation development, and PAT implementations.

Future Trends and Possibilities

Emerging directions in online dissolution analysis include:

• Integration with advanced control systems and AI-driven data analytics.
• Miniaturized fiber optic probes and flow cells for higher throughput.
• Cloud-based data management and real-time remote monitoring.
• Combination with orthogonal techniques (e.g., Raman, NIR) for comprehensive PAT solutions.

Conclusion

Agilent’s Cary 60 online UV-Vis dissolution systems deliver robust, high-throughput analysis for pharmaceutical dissolution testing. With flexible configurations, long lamp life, and regulatory-compliant software, they address critical QC and R&D needs while paving the way for future process analytical technologies.

Reference

No specific literature references were listed in the source document.