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Simultaneous Determination of the Purity and Potency of Vancomycin and Norvancomycin by HPLC

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Abstract

Vancomycin B and norvancomycin of chromatographic purity >99.0%, have been obtained by semi-preparative chromatography. Microbiological assays were used to measure the potency of the purified components, and the quantitative relationship between mass (mg) and potency (units) of pure vancomycin B and norvancomycin was determined. The values obtained were 1,123 units of vancomycin per milligram pure vancomycin B (C66H75Cl2N9O24), with fiducial limits of error (FL) from 1,105 to 1,144 units, and 1,025 units of norvancomycin per milligram pure norvancomycin (C65H72Cl2N9O24), with FL from 1,011 to 1,039 units. The potency (units mg−1) of the main active component of house reference standards of vancomycin and norvancomycin could be determined by HPLC. Thus, in routine quality control, potency and purity could be assayed simultaneously by use of HPLC.

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Acknowledgments

This work was supported by the North China Pharmaceutical Factory (Shijiazhuang, China), and Eli Lilly and Company (Eli Lilly Asia, Inc., Beijing, Rep. Office).

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Authors and Affiliations

  1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing, 100050, People’s Republic of China

    Min Liu & Changqin Hu

  2. Shenzhen Institute for Drug Control, Shenzhen, 518029, People’s Republic of China

    Min Liu

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  1. Min Liu
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  2. Changqin Hu
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Correspondence to Changqin Hu.

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Liu, M., Hu, C. Simultaneous Determination of the Purity and Potency of Vancomycin and Norvancomycin by HPLC. Chroma 65, 203–207 (2007). https://doi.org/10.1365/s10337-006-0134-1

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  • DOI: https://doi.org/10.1365/s10337-006-0134-1

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