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Simvastatin: Excipient & Related
Excellent Peak Shape and Resolution
Method Conditions
| Column |
Cogent Bidentate C18™, 4µm, 100A |
| Catalog No. |
40018-75P |
| Dimensions |
4.6 x 75 mm |
| Mobile Phase |
60:40 Acetonitrile:DI Water + 10mM Sodium Phosphate |
| Flow rate |
1.5 mL/min. |
| Peaks |
1. Excipient
2. Hydrolysis Product
3. Simvastatin
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| Injection Volume |
10 µL |
| Detection |
UV 238 nm |
| Temperature |
30°C |
Discussion
This method is easy to prepare, use and reproduce. Note excellent peak shape and resolution for Simvastatin from its hydrolysis
products and tablet excipients. Separation of a degraded Simvastatin tablet, on a Type C Bidentate C18. USP Tailing Factor is 1.02
for Simvastatin.
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Note: Simvastatin is marketed under the trade names Zocor, Simvastatin, Simlup, Simcard and others. It is a hypolipidemic
drug belonging to the class of pharmaceuticals called "statins". It is used to control hypercholesterolemia (elevated
cholesterol levels) and to prevent cardiovascular disease. Simvastatin is a synthetic derivate of a fermentation product of
Aspergillus terreus.
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