LIQUID-CHROMATOGRAPHIC DETERMINATION OF ALPRAZOLAM AND RELATED IMPURITIES IN THE DRUG SUBSTANCE

A liquid chromatographic method was developed for the determination of alprazolam and 5 known related compounds in drug raw materials. The method is based on a 3 mum cyano column (100 x 4.6 mm), a mobile phase of 0.01 % phosphoric acid-acetonitrile-methanol (6 + 3 + 1), a flow rate of 1.5 mL/min, and detection at 230 nm. The method resolves the related compounds from the drug and from each other. The limit of quantitation for the impurities in drug raw material is less than 0.1 %. Impurity levels in 4 drug raw materials were between 0.01 and 0.41 %. The corresponding mean assay values ranged from 98.3 to 100.6 %.