purpose
Demonstrate the performance of the new ACQUITY UPC 2® Torus TM 2-PIC column for the analysis of low concentrations of drug degradation products.
background
In the production of pharmaceutical compounds, it is extremely important to fully understand any degradation products that may be present, especially in oral preparations. Because of the special nature of such samples, their analysis is extremely challenging. The analysis results of the degraded sample usually contain a large number of peaks, so it is very difficult to separate the active pharmaceutical ingredient (API) and the degradation product. In addition, depending on the parameters, the API may also generate unexpected degradation products. In general, separation can be carried out using liquid chromatography. However, the emergence of another technology, UltraPerformance Convergence ChromatographyTM ( UPC 2® ), enables analysts to perform such difficult separations.
solution
The ACQUITY UPC 2 system takes advantage of liquid CO 2 as a mobile phase to separate complex samples such as drug degradation products. The UPC 2 technology enables orthogonal separation compared to reversed phase chromatography. With the latest column technology from the UPC 2 platform, the ACQUITY UPC 2 Torus column, analysts can quickly analyze such samples. This experiment analyzed the degradation products of omeprazole tablets (used for the treatment of acid reflux and heartburn) using the ACQUTIY UPC 2 system equipped with the new ACQUTIYUPC 2 Torus 2-PIC column. This two-stage bonding technology has a 2-aminomethylpyridine ligand (2-PIC) that provides stable retention and unique selectivity compared to other Torus columns. . The ACQUITY UPC 2 Torus 2-PIC column is a good starting column for the development of supercritical fluid chromatography (SFC) methods.
As shown in Figure 1, the separation of omeprazole in the degradation product was achieved. After using the ACQUITY UPC 2 Torus 2-PIC column, a variety of degradation products, including omeprazole thioether, can be characterized by standard injection or mass spectrometry. The analysis of this article used the new ACQUITY ® QDa ® detector to characterize omeprazole and omeprazole thioether. By combining UPC 2 with a new Torus column, analysts can separate complex matrices while minimizing the amount of organic solvent used in each analysis, effectively reducing the cost of analysis.
to sum up
In this experiment, the acid degradation products of omeprazole preparations were analyzed using a new ACQUITY UPC 2 Torus 2-PIC column. The active pharmaceutical ingredients were successfully separated from all degradation products. By using the ACQUITY UPC 2 Torus 2-PIC column, the degradation peaks are well separated and can be characterized by standard injection or mass spectrometry. The two-stage bonding step of the ACQUITY UPC 2 Torus column ensures stable retention and wide selectivity, making this column family an effective sample analysis tool.
Mushrooms
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