Long-term stability of extemporaneously prepared captopril oral liquids in glass bottles.

Purpose: The long-term stability of captopril in extemporaneously prepared oral liquids was studied.

Methods: Captopril solutions of 1 and 5 mg/mL were prepared in sterile water for irrigation with sorbitol, disodium edetate, and sodium benzoate. The samples were stored in 100-mL amber glass bottles with a headspace of air at 22 degrees C for 12 months. The captopril concentration was determined by high-performance liquid chromatography at 0, 3, 6, 9, and 12 months. The pH of the solutions was also measured, and the physical appearance was recorded. The stability of the 1-mg/mL captopril preparation during 1 month of simulated use when stored at 2-8 degrees C was tested at the start and the end of the 12-month study period. Chemical stability was defined as retention of at least 90% of the initial captopril concentration. The microbiological quality of the preparations was tested at 0, 6, and 12 months (1 mg/mL) and 0 and 12 months (5 mg/mL).

Results: Throughout the 12-month study period, the captopril concentration in the oral liquids exceeded 90% of the initial concentration. The lowest concentration (98.5%) was detected in the 5-mg/mL preparation after 3 months of storage. The 1-mg/mL preparation was stable during 1 month of simulated use, both at the start and the end of the 12-month study period. No microbiological growth was observed in any of the samples tested.

Conclusion: Extemporaneously prepared oral liquid formulations of captopril 1 and 5 mg/mL were chemically stable when stored in glass bottles at room temperature for 12 months when stabilized with 0.1 mg/ mL disodium edetate at a low pH.