THE VALIDATION OF A NEW STABILITY-INDICATING HPLC TECHNIQUE DEVELOPEDFOR THE QUANTITATIVE-ANALYSIS OF ROOPEROL TETRAACETATE

A high performance liquid chromatographic method was developed for the quantitative analysis of rooperol tetra-acetate in the aqueous recept or phase of in vitro diffusion cells. System validation of the develop ed HPLC technique was carried out through the determination of the pre cision, limit of quantitation, sensitivity, linearity, and range of th e system. In each of the above tests mentioned, an isocratic mobile ph ase of acetonitrile/water facilitated the elution of rooperol tetra-ac etate dissolved in acetonitrile. Experimental variations were controll ed through the use of the internal standard, prazepam. The precision r esults, expressed as the percent relative standard deviation, ranged f rom between 1.35% to 4.23%. The results obtained in all other tests pe rformed were acceptable thus verifying that the analytical method used is of good design. Further investigations an rooperol tetra-acetate i nvolved performing stability tests, thus chromatographically character izing the degradation process of the drug. Heat degradation of roopero l tetra-acetate, when stored in a glass vial and a plastic holder, was assessed over a twelve week period. Data evaluation involved the appl ication of the t-distribution test, used to determine if a significant difference, at a 95% confidence level, exists between the drugs store d under heat and a sample stored at room temperature.