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

The rate and extent of drug dissolution from solid dosage forms directly impact bioavailability and therapeutic efficacy.
Implementing real-time, in situ UV-Vis analysis advances quality control and accelerates pharmaceutical development.

Objectives and Study Overview

This study evaluates the Agilent Cary 60 UV-Vis spectrophotometer equipped with Torlon fiber optics for in situ monitoring of anti-malarial tablet dissolution.
It compares calibration performance and assesses time and cost savings versus conventional sampling.

Methodology and Instrumentation

The dissolution test followed British Pharmacopoeia 2011 guidelines using an Agilent Cary 60 with a Torlon fiber optic probe and coupler.
A blank in isopropanol established baseline absorbance; six standards (0–300 mg/L API) generated a calibration curve via WinUV software.
Sample concentrations were measured directly in the dissolution bath to determine total dissolved active ingredient.

• Agilent Cary 60 UV-Vis Spectrophotometer (G6860AA)
• Torlon fiber optic probe (7910029900)
• Torlon fiber optic probe coupler (G6866A)

Key Results and Discussion

The calibration curve exhibited excellent linearity (R2=0.99976) over 0–2 absorbance units.
Analysis of three independent samples yielded a mean API concentration of 281.4 mg/L with a relative standard deviation of 0.30%.
These data confirm the method’s precision and suitability for routine dissolution profiling.

Benefits and Practical Applications

In situ fiber optic measurement eliminates manual sampling and off-line analysis, reducing turnaround times and contamination risk.
Integration with 21 CFR Part 11–compliant software ensures regulatory traceability.
The approach is particularly cost-effective for low-to-medium throughput laboratories.

Future Trends and Opportunities

Expanding to fully automated fiber optic dissolution systems can increase sample throughput and unattended operation.
Adaptation to other dosage forms and active ingredients will broaden applicability.
Integration with laboratory information management systems will enhance data workflow and regulatory reporting.

Conclusion

The Agilent Cary 60 UV-Vis with fiber optics enables rapid, accurate, and regulatory-compliant in situ dissolution analysis.
This method streamlines pharmaceutical quality control and supports efficient drug development.

Reference

British Pharmacopoeia 2011. Volume III: Formulated Preparations, Specific Monographs.