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Related Experiment Videos

Stability of ranitidine in injectable solutions.

Midhat Vehabovic1, Sabira Hadzovic, Fatima Stambolic

  • 1Bosnalijek d.d., Jukiceva 55, 71000, Sarajevo, Bosnia and Herzegovina.

International Journal of Pharmaceutics
|April 16, 2003
PubMed
Summary

Injectable ranitidine solutions remained stable only when stored at 25 degrees C. Higher temperatures (40 and 55 degrees C) led to instability, impacting the quality of this essential medication.

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Area of Science:

  • Pharmaceutical Sciences
  • Formulation Development
  • Stability Testing

Background:

  • Ranitidine hydrochloride is a widely used medication.
  • Injectable formulations require rigorous stability assessment to ensure efficacy and safety.
  • Oxidative degradation and temperature sensitivity are key concerns for pharmaceutical solutions.

Purpose of the Study:

  • To evaluate the stability of injectable ranitidine hydrochloride solutions.
  • To determine the optimal storage conditions for maintaining ranitidine formulation integrity.
  • To assess the impact of temperature on ranitidine and phenol content and related substances.

Main Methods:

  • Preparation of ranitidine hydrochloride solutions with a specific buffering system (disodium phosphate, potassium dihydrogen phosphate) and phenol preservative.

Related Experiment Videos

  • Storage of ampoules under nitrogen at 25°C, 40°C, and 55°C for extended periods.
  • Stability monitoring using Thin Layer Chromatography (TLC) for related substances and High-Performance Liquid Chromatography (HPLC) for ranitidine and phenol content.

    • Main Results:

    • Ranitidine hydrochloride solutions stored at 25°C demonstrated stability over 12 months.
    • Samples stored at elevated temperatures (40°C and 55°C) for 6 months exhibited instability.
    • TLC and HPLC analyses confirmed degradation and loss of active components at higher temperatures.

    Conclusions:

    • Refrigerated or controlled room temperature storage (25°C) is critical for maintaining the stability of injectable ranitidine hydrochloride formulations.
    • Elevated temperatures accelerate degradation, compromising the quality and therapeutic effectiveness of the drug.
    • The study highlights the importance of strict temperature control during storage of ranitidine injections.