USP-Compliant Analysis and Robustness Evaluation of Pramipexole by Integrated LC System

Importance of the Topic

Analysis of pramipexole as a pharmaceutical compound requires reliable methods to meet regulatory standards and ensure patient safety. Robust method transfer between instruments reduces development time and maintains data integrity.

Goals and Overview of the Study

This study assessed the compatibility of a new HPLC system (LC-2070C with delay volume kit) with a legacy system (LC-2010) for USP-compliant analysis of pramipexole hydrochloride. Additionally, method robustness was evaluated using an AQbD approach enabled by LabSolutions MD.

Methodology

System suitability tests measured resolution and symmetry factor under USP-specified conditions. Robustness was probed by varying flow rate (1.4–1.6 mL/min) and column temperature (39–41 °C) in a 3×3 design. Chromatograms were compared and design spaces were generated for critical parameters.

Used Instrumentation

• Shimadzu i-Series LC-2070C with delay volume compatibility kit
• Shimadzu LC-2010 HPLC system
• Shim-pack Scepter C18-120 column (150×4.6 mm, 5 µm)
• PDA detector at 264 nm
• LabSolutions MD software for AQbD-based robustness evaluation

Main Results and Discussion

Chromatograms from both systems were nearly identical, confirming delay volume compatibility. System suitability criteria were met with resolution values >9.9 and symmetry factors around 0.93–0.95. Design space plots showed minimal variation across the tested range, indicating strong method robustness.

Benefits and Practical Application of the Method

The validated method allows seamless transfer between HPLC systems, reducing revalidation efforts and ensuring compliance. The AQbD-driven robustness assessment supports method lifecycle management without extensive chromatographic expertise.

Future Trends and Possible Applications

Future developments may include integration of machine learning for predictive method optimization, expansion to other pharmaceutical compounds, and further automation of AQbD workflows to accelerate regulatory submissions.

Conclusion

The study demonstrates effective method transfer between LC-2070C and LC-2010 for pramipexole analysis, with robust performance validated via design space evaluation. Adoption of AQbD tools enhances reliability and efficiency in analytical method management.

References

• US Pharmacopeia 43-NF38, 2022. Pramipexole Dihydrochloride.