Abstract:
OBJECTIVE To establish a method to determine the dissolution of Compound Paracetamol tablets and evaluate the dissolution curves of different samples.
METHODS The HPLC was used, and the separation was performed on a Sepax Amethyst C
18-H(4.6 mm×150 mm, 5 μm) column with the mobile phase consisted of phosphate buffer (0.01 mol·L
-1 potassium dihydrogen phosphate solution adjust pH to 2.6±0.1 by phosphoric acid)-methanol (70︰30) at a flow rate of 1.0 mL·min
-1. The column temperature was 35℃. The detection wavelength was 275 nm at 0-12.5 min and switched to 303 nm at 12.5-16 min. The paddle method was used for the dissolution test with hydrochloric acid solution(dissolve 24 mL dilute hydrochloric acid in water to 1 000 mL) as the medium and the rotation rate was set at 50 r·min
-1.
RESULTS Aspirin and salicylic acid revealed good linearities within the range of 12.54-501.60 μg·mL
-1(
r=1.000 0) and 0.99-39.76 μg·mL
-1(
r=0.999 9), respectively. The average recoveries were 98.9%, 96.7%, 97.7% at low, intermediate and high concentration, with the RSD of 0.46%, 0.65%, 0.31%, respectively. The dissolution method was suitable, which showed differences of dissolutions among products of different manufacturers.
CONCLUSION The established HPLC method is simple, which shows good specificity, precision and accuracy. The dissolution method can reflect differences among products of different manufacturers.