This document describes the in-process control for Aripiprazole manufacturing using the Agilent 1120 Compact LC and Agilent TC C18(2) columns. The compact LC system is designed for easy use, high performance, and reliability, making it well-suited for in-process control in the pharmaceutical industry. The document also shows excellent retention time precision and peak area precision.
This document describes an HPLC method developed for the simultaneous determination of Aripiprazole and its precursor products during manufacturing. The study highlights the system's ability to provide reproducible results with high precision for retention times and peak areas.
The Agilent 1120 Compact LC system, controlled by EZChrom Elite Compact Compliance software, was used to analyze samples containing varying concentrations of starting materials and the final product. The method utilizes an Agilent TC-C18(2) column with specific mobile phases and gradient conditions to achieve baseline separation within a 9-minute run time.
| Column dimensions | 150 x 4.6 mm |
|---|---|
| Particle size | 5 pm |
| Flow rate | 1.0 mL/min |
| Injection volume | 5 pL |
| Detection wavelength | 254 nm |
| Run time | 9 min |
The instrument is controlled by Agilent EZChrom Elite Compact Compliance software.
The total run time, including equilibration and re-equilibration, can be limited to 14 minutes.