The document introduces the system suitability testing for Aripiprazole quality control using Agilent 1120 Compact LC and Agilent TC C18(2) columns. The system provides highly precise retention times and peak areas, as well as low detection limits, making it suitable for drug analysis.
This document serves as an application note detailing the use of the Agilent 1120 Compact LC system for system suitability testing (SST) of Aripiprazole and its precursors in the pharmaceutical industry. It highlights the system's reliability and precision for analyzing drugs and impurities.
The note outlines the experimental setup, including the specific Agilent TC C18(2) column and EZChrom Elite Compact Compliance software used. It presents chromatographic parameters, acceptance criteria based on ICH recommendations, and results from a system suitability test involving replicate injections to verify retention time, peak area, resolution, and other critical parameters.
| Flow rate | 1.0 mL/min |
|---|---|
| Column oven temperature | 40 °C |
| Detection wavelength | 254 nm |
The relative standard deviation (RSD) of retention time must be less than 0.07%.
The RSD of area must be less than 1.00%.
The resolution must be greater than 2.00.