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[Streptokinase: correlation between different methods of biological evaluation]

L M Oliva1, M V Guagliardo, M E Albertengo

  • 1Departamento de Productos Biológicos, Instituto Nacional de Medicamentos, Buenos Aires, Argentina.

Sangre
|September 19, 1998
PubMed
Summary

This study evaluated methods for determining streptokinase (SK) potency. The clot lysis and chromogenic methods are precise and reproducible for SK potency determination in commercial products.

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Area of Science:

  • Pharmacology
  • Biotechnology
  • Analytical Chemistry

Background:

  • Streptokinase (SK) is a vital thrombolytic agent.
  • Accurate potency determination is crucial for pharmaceutical quality control.
  • Regulatory bodies require validated biological assays for drug products.

Purpose of the Study:

  • To establish an appropriate biological assay for streptokinase (SK) potency determination.
  • To ensure the quality of SK products marketed in Argentina.
  • To compare the precision and reproducibility of different SK assay methods.

Main Methods:

  • Comparison of three internationally accepted methods: fibrin plate, clot lysis, and chromogenic assay.
  • Determination of SK potency against the International Standard.

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  • Statistical analysis of assay results, including correlation coefficients.

    • Main Results:

    • The fibrin plate method showed the least precision and reproducibility.
    • The clot lysis and chromogenic methods demonstrated high precision and reproducibility.
    • A correlation coefficient of 0.99 was observed between the clot lysis and chromogenic methods.

    Conclusions:

    • Both clot lysis and chromogenic methods are suitable for determining the potency of commercial streptokinase products.
    • These validated methods support regulatory compliance and ensure product quality.
    • The findings aid the Instituto Nacional de Medicamentos in its quality assurance functions.