Stability of captopril in powder papers under three storage conditions.

ABSTRACT

The stability of captopril in powder papers under three different storage conditions was determined. Captopril 12.5-mg tablets were triturated with lactose to a final concentration of 2 mg of captopril in 100 mg of powder. A total of 240 powder papers were prepared and stored in class "A" prescription vials (80 papers), 002G plastic zip-lock bags (80 papers), and Moisture Proof Barrier Bags (80 papers). Immediately after preparation and at 1, 2, 3, 4, 8, 12, and 24 weeks of storage at room temperature, powder papers under each storage condition were reweighed and the contents were assayed for captopril concentration by a stability-indicating high-performance liquid chromatographic method. More than 90% of the initial captopril concentration was retained under all storage conditions during the first 12 weeks of the study. Captopril disulfide, a degradation product, was detected in one sample stored in a plastic zip-lock bag at 24 weeks. Captopril was stable for the entire 24-week period in powder papers stored in either the class A prescription vial or the Moisture Proof Barrier Bag. Captopril in powder papers is stable for at least 12 weeks when stored at room temperature under all three storage conditions.