This document describes a method for USP purity analysis of pravastatin sodium using Agilent 1120 Compact LC. The system suitability parameters of the method (including resolution, recovery and repeatability) meet USP requirements. The detector of Agilent 1120 Compact LC has a linear response to related compound A, with a detection limit of 0.09 µg/mL.
This document describes a method for analyzing the purity of Pravastatin Sodium using High-Performance Liquid Chromatography (HPLC) on an Agilent 1120 Compact LC system. The study validates the system's suitability parameters and demonstrates the detector's linearity response at low concentrations as per United States Pharmacopeia (USP) guidelines.
The application details experimental procedures including sample preparation, system suitability testing, and impurity analysis. Results confirm that the Agilent 1120 Compact LC meets USP requirements for resolution, precision, and linearity when analyzing Pravastatin Sodium and its related compounds. This manual is written in Japanese.
The concentration of Related Compound A in the system suitability test sample was set to 0.001 mg/mL.
The RSD value obtained was 0.3%.
The correlation coefficient (R2) was 0.998.