USP-Compliant Analysis and Robustness Evaluation of Pramipexole by i-Series

User Benefits

- LC-2050C, with delay volume compatibility kit, is compatible with the delay volume of LC-2010, facilitating smooth method transfer. - Design space generated by LabSolutions MD allows robustness evaluation of a test method without relying on the user's experience in chromatography.

Introduction

Pramipexole is a drug used to treat Parkinson's disease and other disorders. The United States Pharmacopeia (USP) specifies analytical conditions for this drug. "i-Series LC-2050C" integrated high-performance liquid chromatograph is equipped with delay volume compatibility with LC-2010, our former integrated HPLC, by using the optional delay volume compatibility kit. This compatibility ensures a smooth method transfer from LC-2010. In this paper, a case study is presented, analyzing Pramipexole hydrochloride, a compound listed in the USP, utilizing LC-2050C with the delay volume compatibility kit. The scientific basis (specificity and robustness) of the test method for the instrument change from LC-2010 to LC-2050C was evaluated using LabSolutions MD which is a dedicated software for supporting method development. Specifically, the effect on system suitability test, such as resolution and symmetry factor, was assessed by intentionally varying the flow rate and column oven temperature specified by the USP within a small range.

27 de febrero de 2024 GMT