The Stability Assessment of Extemporaneous Preparations of Acetazolamide of The Queen Sirikit National Institute of Child Health (QSNICH)

Abstract

Introduction: The study determined physical and chemical stability of extemporaneous preparations  of acetazolamide suspension (10 mg/ml)  in  light-resistant  containers. Materials and Methods: All acetazolamide suspensions were randomly sampled and stored at refrigerated temperature (2-8°C), room temperature (25-28°C) or accelerated temperature (45°C). The changes in physical characteristics such as color and reversible precipitation of suspensions were determined. The chemical characteristics were measured by pH value and the remaining drug contents analyzed using reversed phase HPLC at 0, 7, 14, 21, 28 and 42 days. The acceptable range of remaining drug content was 90-110% of the initial content. Results: It was found that physical characteristics and pH of extemporaneous preparations of acetazolamide were unchanged at all conditions on keeping for 42 days. Drug contents remaining  at room temperature (25-28°C) and refrigerated temperature (2-8°C) were in the acceptable range through to 42 days. At accelerated temperature (45°C), drug remaining in all suspensions was in the acceptable range for 28 days and then decreased less than 90% of the initial content. Conclusion: The extemporaneous preparations of acetazolamide can be kept at room temperature (25-28°C) or refrigerated temperature (2-8°C) in light-resistant containers for at least 42 days with no significant change.