STABILITY STUDIES OF METRONIDAZOLE SUSPENSION UNDER VARYING ENVIRONMENTAL AND STORAGE CONDITIONS USING PET BOTTLES
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Abstract
Background: Metronidazole, a widely used antimicrobial agent, is susceptible to environmental factors that may compromise its stability and efficacy. This study investigates the stability of metronidazole suspension stored in polyethylene terephthalate (PET) bottles under different environmental conditions. Given the potential interaction between PET packaging and liquid pharmaceuticals, it is crucial to assess how temperature, light exposure, and pH affect drug degradation.
Aim: The purpose of this study is to evaluate the stability of metronidazole suspension under various environmental conditions to determine the optimal storage practices and highlight the impact of temperature, light exposure, and packaging materials on drug degradation and drug concentrations.
Method: Metronidazole suspensions were formulated and stored under various conditions, including refrigerator (4°C), room temperature (25°C), elevated temperature (55°C), sunlight exposure (38°C), and acidic and basic pH environments. Spectrophotometric analysis at 277 nm was conducted weekly for 10 weeks to determine the concentration of metronidazole remaining in each sample. The percentage of the drug remaining was calculated for each condition to evaluate the extent of degradation.
Result: By week 10, samples stored under elevated temperature (55°C) and sunlight exposure (38°C) showed significant degradation, with metronidazole content reduced to 27.33% and 41.90%, respectively. At room temperature (RT) it reduced to 76.34%, at acidic pH (AP) to 69.04%, and basic pH (BP) to 58.62%. Refrigerated storage (4°C) and dark storage provided optimal stability, maintaining over 94% of the initial drug concentration.
Discussion: The results indicate that temperature and light are critical factors affecting the stability of metronidazole in suspension. Elevated temperatures accelerate degradation, likely due to increased hydrolysis and photodegradation. In contrast, refrigeration effectively preserves the drug’s stability, reducing the risk of degradation. These findings emphasize the importance of storage conditions for maintaining the efficacy of metronidazole.
Conclusion:
Refrigeration and storage in light-protected environments are recommended for main taining the stability of metronidazole suspension. Further studies on alternative packaging materials and the long-term effects of extreme pH conditions could provide additional insights into improving drug formulation and packaging
Aim: The purpose of this study is to evaluate the stability of metronidazole suspension under various environmental conditions to determine the optimal storage practices and highlight the impact of temperature, light exposure, and packaging materials on drug degradation and drug concentrations.
Method: Metronidazole suspensions were formulated and stored under various conditions, including refrigerator (4°C), room temperature (25°C), elevated temperature (55°C), sunlight exposure (38°C), and acidic and basic pH environments. Spectrophotometric analysis at 277 nm was conducted weekly for 10 weeks to determine the concentration of metronidazole remaining in each sample. The percentage of the drug remaining was calculated for each condition to evaluate the extent of degradation.
Result: By week 10, samples stored under elevated temperature (55°C) and sunlight exposure (38°C) showed significant degradation, with metronidazole content reduced to 27.33% and 41.90%, respectively. At room temperature (RT) it reduced to 76.34%, at acidic pH (AP) to 69.04%, and basic pH (BP) to 58.62%. Refrigerated storage (4°C) and dark storage provided optimal stability, maintaining over 94% of the initial drug concentration.
Discussion: The results indicate that temperature and light are critical factors affecting the stability of metronidazole in suspension. Elevated temperatures accelerate degradation, likely due to increased hydrolysis and photodegradation. In contrast, refrigeration effectively preserves the drug’s stability, reducing the risk of degradation. These findings emphasize the importance of storage conditions for maintaining the efficacy of metronidazole.
Conclusion:
Refrigeration and storage in light-protected environments are recommended for main taining the stability of metronidazole suspension. Further studies on alternative packaging materials and the long-term effects of extreme pH conditions could provide additional insights into improving drug formulation and packaging
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