Agilent Online UV-Vis Dissolution Systems

Importance of Topic

Automated online UV-Vis dissolution analysis plays a critical role in pharmaceutical research and quality control by enabling continuous monitoring of drug release profiles. It reduces manual intervention, improves data reliability, and accelerates decision making during formulation development and regulatory compliance.

Objectives and Overview

This document presents Agilent’s integrated Online UV-Vis Dissolution Systems based on the Cary 60 spectrophotometer. Two main configurations are described: a multicell UV dissolution system and a fiber optic UV dissolution system. Both solutions aim to streamline dissolution testing workflows and ensure accurate, reproducible measurements.

Methodology and Instrumentation

Both configurations use the Cary 60 UV-Vis Spectrophotometer featuring a xenon flash lamp, 190–1100 nm wavelength range, 1.5 nm slit width, and scanning design. Key sampling modules include:

• Multicell changer: integrates one or two dissolution vessels, each with its own flow cell (0.2–10 mm path lengths), peristaltic pump or 850-DS Sampling Station for filtration and sampling.
• Fiber optic multiplexer: supports one or two vessels, in situ sampling via silica fiber probes with interchangeable tips (1–20 mm path lengths), precise positioning and minimal hydrodynamic disturbance.
• Cary WinUV software with 21 CFR Part 11 compliance (SCM/SDA) for data acquisition, processing, reporting, and secure electronic records.

Main Results and Discussion

The multicell system accommodates up to eight flow cells per apparatus, allowing simultaneous blank, standard, and sample measurements, eliminating cross-contamination through dedicated flow paths. The fiber optic system enables rapid time-point readings (as fast as every 45 seconds) directly in the vessel, correcting for background interferences. The Cary 60 spectrophotometer delivers photometric accuracy of ±0.005 Abs, noise below ±0.0001 Abs, and a linear range exceeding 3.5 Abs, surpassing pharmacopeia requirements. Software flexibility supports offline sample archiving, HPLC integration, media change methods, and customizable reporting.

Benefits and Practical Applications

• High throughput and reduced labor through automation of sampling and analysis.
• Improved measurement precision and elimination of cross-contamination.
• Versatile configurations for both standardized multicell workflows and flexible in situ fiber optic assays.
• Seamless integration with HPLC for confirmatory analysis and sample archiving.
• Regulatory compliance support via electronic records and audit trails.

Future Trends and Potential Uses

Advancements in online dissolution analysis may include integration with real-time data analytics and machine learning for predictive release profiling, further miniaturization of optical probes for microdissolution assays, expansion into continuous manufacturing process analytical technology (PAT), and cloud-based data management platforms to enable remote monitoring and collaboration.

Conclusion

Agilent’s Online UV-Vis Dissolution Systems based on the Cary 60 offer robust, accurate, and automated solutions for pharmaceutical dissolution testing. Their flexible multicell and fiber optic configurations, combined with powerful software and compliance features, provide a complete platform for modern laboratories seeking efficiency and regulatory adherence.

Instrumentation

• Cary 60 UV-Vis Spectrophotometer (xenon flash lamp, 190–1100 nm).
• Agilent 708-DS Dissolution Apparatus.
• Multicell changer and rotary multiplexer modules.
• 850-DS Dissolution Sampling Station and peristaltic pump.
• Fiber optic multiplexer, silica fiber probes, interchangeable tips.
• Cary WinUV software with Spectroscopy Configuration Manager (SCM) and Spectroscopy Database Administrator (SDA).