Transfer of USP Methods for Impurities Analysis of Ziprasidone HCl between HPLC Systems and to UPLC

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Margaret Maziarz, Michael D. Jones, Sean M. McCarthy, Warren B. Potts, and Frederic Forini
Waters Corporation
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Application Notes
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Application Notes
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Transferring compendial HPLC methods between systems can be challenging. Many of the USP monographs utilize diluents with a high concentration of organic solvents for the preparation of standard and sample solutions. While strong solvent diluents are common for HPLC applications, they often prove unsatisfactory for analyses performed on modern systems that feature minimized dispersion.

In this study, the transfer of two USP compendial methods for impurities analysis of ziprasidone HCl from HPLC to UPLC is demonstrated. The use of strong solvent as a sample diluent can be a barrier when transitioning a method to a low-volume system, depending on the injection volume. Presented here is a straightforward way to address this potential issue.

The HPLC method was first run using an XBridge C8 4.6 x 150 mm, 5-µm column on an Alliance HPLC System, and then on the ACQUITY UPLC H-Class System, which is capable of running both HPLC and UPLC. The method was then transferred to UPLC using the ACQUITY UPLC H-Class System, an ACQUITY UPLC BEH C8 2.1 x 50 mm, 1.7-µm column, along with the ACQUITY UPLC Columns Calculator.

The success of the method transfer between different HPLC systems and conversion to UPLC was measured by evaluating the system suitability requirements listed in the USP monograph for ziprasidone HCl. Success of the transfer was further demonstrated by running the methods on the same instrument configurations in a laboratory located in a different country, where identical results were achieved.

Transferring the method from HPLC to UPLC additionally demonstrates:

  • 63% reduction in run time when using UPLC
  • 93% savings in mobile phase consumption when using UPLC
  • Reduced cost for solvent and waste disposal
  • Method transferability between different systems and different sites

See also:

Transfer of Two USP Compendial Methods for Impurities of Ziprasidone HCl to a Single UPLC Method

Application Notebook: Transferring Compendial HPLC Methods to UPLC Technology

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