Transfer of the USP Assay for Simvastatin to UPLC

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Paul Rainville and Robert Plumb
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Application Notes
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Application Notes
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Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. The Uniformity of Content Assay for simvastatin is accomplished using high performance liquid chromatography (HPLC) with ultraviolet detection (UV). The faster that this assay can be performed, the faster the finished product can be released and revenue realized. In this application note, we show how the HPLC assay for simvastatin has been transferred to UPLC. The UPLC assay is compared to the USP assay criteria for performance and quality.

The final methodology reduced the analysis time from an analyte retention of 9.28 minutes with HPLC to an analyte retention of just 1.41 minutes with UPLC (a seven-fold increase in throughput).

The ACQUITY UPLC Console Calculator was used to easily guide the transfer methodology to ACQUITY UPLC using sub-2 µm particles. The calculator gave three separate options for UPLC methods: Equal Efficiency, Maximum Efficiency and Shortest Analysis Time conditions.

We demonstrate the ease of HPLC to UPLC method transferability, and the benefits that can be obtained in any time-, resource- and/or revenue-conscious laboratory environment where UPLC can significantly increase throughput with quality results. And with a variety of ACQUITY UPLC BEH Column dimensions, scientists have the flexibility to tailor their UPLC separations to the goals at hand.

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