Using the Agilent 1200 Series Rapid Resolution LC system and Agilent Method Translator software, USP pravastatin sodium chromatographic purity method is used to conduct a fast LC analysis. This application note describes how to start from a USP method, incorporate the allowed adjustments, and produce a fast method that meets system suitability requirements.
Recent revisions in United States Pharmacopeia (USP) general chapter <621> allow for adjustments to chromatographic parameters to enhance chromatogram quality and reduce run times. This document details a case study where a standard 30-minute USP method was optimized into a faster method using the Agilent 1200 Series Rapid Resolution LC (RRLC) system.
The study utilizes Agilent Method Translator software to adjust parameters such as particle size, flow rate, column dimensions, and temperature. The optimized method uses a 1.8 µm particle column and a 1.5 mL/min flow rate, significantly reducing analysis time while maintaining system suitability requirements for pravastatin sodium and its impurities.
| Column dimensions (Fast method) | 4.6 mm x 30 mm |
|---|---|
| Column particle size (Fast method) | 1.8 µm |
| Flow rate (Fast method) | 1.5 mL/min |
| Column temperature (Fast method) | 35 °C |
| Wavelength for DAD | 238 nm |
| System | Agilent 1200 Series Rapid Resolution system |
The fast method is developed by using Agilent Method Translator software to incorporate allowed USP adjustments such as smaller particle size and higher flow rates.
Permitted adjustments include column length, column inner diameter, particle size, flow rate, injection volume, and column temperature.
Yes, the fast method meets requirements with an RCA RRT of about 1.1 and a resolution of 3.8.