ABSTRACT
OBJECTIVE: To establish a method for quantitative analysis of the impurities in vardenafil hydrochloride orally disintegrating tablets. METHODS: Gradient elution at the flow rate of 1.0 mL·min-1 was used for the determination of known impurities A-E and the unknown impurities simultaneously. The separation was performed on Athena C18-WP column (4.6 mm×250 mm,5 μm) with acetate solution containing 0.8g ammonium acetate in 900 mL of water-acetonitrile (90:10) as mobile phase A and acetate solution containing 0.8g ammonium acetate in 100 mL of water-acetonitrile (10: 90) as mobile phase B. The UV detection was carried out at 245 nm, and the column temperature was maintained at 40℃. RESULTS: After being treated with oxidation, heat, and light, vardenafil underwent more or less degradation. The degradation products were effectively separated and detected using this method. Meanwhile, the method showed good specificity, linearity, and ruggedness. CONCLUSION: The method is selective, sensitive, and accurate, and it is suitable for the quality control of vardenafil hydrochloride orally disintegrating tablets.