This application note describes the method for purity analysis of pravastatin sodium using the Agilent 1120 Compact LC. The method is established by the United States Pharmacopeia (USP) and validated on the Agilent 1120 Compact LC.
This document describes the verification of the United States Pharmacopeia (USP) chromatographic method for determining the purity of pravastatin sodium. The study was conducted using the Agilent 1120 Compact LC system to ensure the instrument meets the required system suitability parameters specified by the USP monograph.
The analysis involved testing system suitability using a mixture of pravastatin 1,1,3,3-tetramethylbutylamine and Related Compound A, which demonstrated a resolution of 6.3, exceeding the acceptance limit of 2.0. Additionally, the method's precision and the detector's linearity were verified, with a relative standard deviation (RSD) of 0.3% for peak areas and a correlation coefficient (R2) of 0.998 for the detector response.
| Flow rate | 1 mL/min |
|---|---|
| System suitability resolution | 6.3 |
| Detector linearity R2 | 0.998 |
The system suitability mixture displayed a resolution of 6.3, which is well above the acceptance limit of not less than 2.0.
A value of 0.3% RSD was obtained for the peak areas of pravastatin, suggesting excellent precision.
The linearity plot showed a correlation coefficient (R2) of 0.998 for the Related Compound A impurity.