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Controlled-release penicillin complexes. High-performance liquid chromatography and assay.

W J Irwin, J M Hempenstall, A Li Wan Po

    Journal of Chromatography
    |March 30, 1984
    PubMed
    Summary

    New HPLC methods accurately measure multiple penicillin complexes in drug formulations. These assays simultaneously quantify both components of controlled-release penicillin drugs, ensuring quality control for injections and suspensions.

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    Area of Science:

    • Analytical Chemistry
    • Pharmaceutical Analysis

    Background:

    • Controlled-release penicillin complexes are crucial in veterinary and human medicine.
    • Accurate quantification of these complexes is essential for ensuring therapeutic efficacy and product quality.
    • Existing analytical methods may not efficiently analyze multiple penicillin complexes simultaneously.

    Purpose of the Study:

    • To develop and validate high-performance liquid chromatographic (HPLC) assays for five specific controlled-release penicillin complexes.
    • To enable simultaneous determination of both active components within each penicillin complex.
    • To demonstrate the applicability of the developed methods to complex pharmaceutical formulations.

    Main Methods:

    • Utilized reversed-phase ion-paired chromatography.

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  • Employed aqueous acetonitrile mobile phases for optimal separation.
  • Applied the methods to analyze various drug formulations, including injections and suspensions.

    • Main Results:

    • Successfully developed HPLC assays for benzathine-cloxacillin, benzathine-penicillin V, procaine-penicillin G, benethamine-penicillin G, and benzathine-penicillin G.
    • Achieved simultaneous determination of both components in each penicillin complex.
    • Demonstrated method utility in analyzing fortified injections and suspensions containing multiple preservatives.

    Conclusions:

    • The developed reversed-phase ion-paired HPLC methods provide a robust and efficient means for analyzing controlled-release penicillin complexes.
    • These assays are suitable for quality control of diverse pharmaceutical preparations containing these antibiotics.
    • The simultaneous quantification capability offers an advantage over methods requiring separate analyses.