부산대학교 도서관

Objective: To develop a validated stability-indicating assay method (SIAM) for aripiprazole after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis and thermal stress conditions. Methods: The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm 4.6 mm i.d.) using a mobile phase containing acetonitrile:methanol (80:20, v/v) at a flow rate of 1 ml/min and UV detection at 254 nm. Results: The method was linear over the concentration range of 10-60 μg/ml (r = 0.998) with a limit of detection and quantization of 2.85 and 8.56 μg/ml, respectively. The method has the requisite accuracy, specificity, sensitivity and precision to assay aripiprazole in bulk form and pharmaceutical dosage forms. Conclusion: Degradation products resulting from the stress studies did not interfere with the detection of aripiprazole and the assay is thus stability-indicating. [ABSTRACT FROM AUTHOR]