This Application Note describes the System Suitability Testing (SST) results of Aripiprazole quality control with the Agilent 1120 Compact LC and ZORBAX C-18 columns. The system is shown to have excellent precision in retention time, area and height measurements.
This Application Note evaluates the performance of the Agilent 1120 Compact LC system for the analysis of Aripiprazole and its precursor impurities. The study focuses on System Suitability Testing (SST) to verify instrument precision and accuracy for pharmaceutical quality control applications.
The document details the experimental setup, including the use of an Agilent ZORBAX Eclipse XDB C18 column and Agilent EZChrome Elite Compact Compliance software. It presents results from 10 replicate injections, confirming that the system meets stringent acceptance criteria for retention time, peak area, resolution, and theoretical plates.
| Column | Agilent ZORBAX Eclipse XDB C18, 5µm, 150 x 4.6 mm |
|---|---|
| Flow rate | 1.0 mL/min |
| Column oven temperature | 40 °C |
| Detection wavelength | 254 nm |
| Injection volume | 10 µL |
| Total run time | 9 min |
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.