This article describes a HPLC analysis method for the USP assay of ibuprofen and the limit test of ibuprofen-related compound C in ibuprofen tablets using Varian 920-LC liquid chromatograph and Varian Pursuit C18 column. The experimental results show that this method has high sensitivity and selectivity and can be used for rapid analysis of ibuprofen-related compound C.
The document describes an experiment to perform the United States Pharmacopoeia (USP) monograph Limit Test for ibuprofen-related compound C in ibuprofen tablets. The analysis was carried out using a Varian 920-LC liquid chromatograph equipped with a low pressure quaternary gradient pump, diode array detector, and autosampler.
The study compares the performance of a standard Pursuit XRs C18 column (5 µm, 250x4.6 mm) against a shorter, faster column (3 µm, 100x4.6 mm). Results show that the optimized method achieves run times below 4 minutes while surpassing USP acceptance criteria for resolution and peak asymmetry.
| Column (Assay) | Pursuit XRs C18, 5 µm, 250x4.6 mm |
|---|---|
| Column (Limit Test) | Pursuit XRs C18, 3 µm, 100x4.6 mm |
| Mobile Phase | Chloroacetic acid in water (1% w/v) pH=3 : acetonitrile (40:60 % viv) |
| Flow Rate | 2 ml/min |
| Wavelength (UV) | 254 nm |
The amount of ibuprofen-related compound C must be not more than 0.1% per tablet.
The run times can be reduced to below 4 minutes, which is less than half the run times from the original method.