This document describes the improvement of simvastatin analysis performance using Agilent ZORBAX Eclipse Plus C18 columns with different particle sizes. By making simple adjustments, the USP method can be adapted to Rapid Resolution Eclipse Plus C18 3.5µm columns or Rapid Resolution HT Eclipse Plus C18 1.8µm columns, resulting in shorter analysis time and significant solvent savings.
This document details the optimization of a USP method for analyzing simvastatin tablets. The original method utilizes an Agilent ZORBAX Eclipse Plus C18 5 µm column (250 mm x 4.6 mm) with a 10-minute analysis time.
The note demonstrates how to modify this method using smaller particle sizes and shorter columns, specifically the Rapid Resolution Eclipse Plus C18 (3.5 µm) and Rapid Resolution HT Eclipse Plus C18 (1.8 µm). These modifications significantly reduce analysis time and solvent usage while maintaining performance requirements. This manual is written in Japanese.
| Original Column Part Number | 959990-902 |
|---|---|
| Rapid Resolution Column Dimensions | 4.6 mm x 100 mm, 3.5 µm |
| Flow Rate | 1.5 mL/min |
| Column Temperature | 45 °C |
| Detection Wavelength | 238 nm |
The original USP method requires a 10-minute analysis time.
The method requires a flow rate of 1.5 mL/min.
The column must be kept at a constant temperature of 45 C.
All listed columns can be used with pressures under 400 bar.