Abstract
An analytical procedure for the analysis of 9-(ß-D-arabinofuranosyl)-adenine (ara-A) was developed and used to determine its solubility as well as stability. A reversed-phase high performance liquid chromatographic method was used to quantitate intact drug and to determine its degradation products in aqueous solutions. The solubility of ara-A was determined in different cosolvent-water mixtures as well as in different pH-buffers. The aqueous solubility of ara-A increased exponentially with a linear increase in the volume fraction of the cosolvent. Stability studies indicate that ara-A is relatively stable in dimethylsulfoxide, dimethylacetamide, and dimethylformamide. In vitro precipitation was studied to evaluate the relative potential for precipitation of the drug on injection. Based on these findings, ara-A may be dissolved in the 70% dimethylsulfoxide-water mixture at 15 mg/ml and injected at a rate of 2 ml/min.
- Received September 15, 1986.
- Accepted November 28, 1986.
- Copyright © Parenteral Drug Association. All rights reserved.
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