ABSTRACT
Objective To establish a method for the determination of the content and dissolution of isophenylcyclopentyl?amine hydrochloride capsules. Methods The HPLC analysis was performed on a Diamonsil C18 column(150 mm×4.6 mm,5μm). A mixture of 0.02 mol/L KH2PO4 solution containing 0.1%triethylamine with pH adjusted to 3.0 by phosphoric acid-methanol-acetonitrile (30:35:35)was used as the mobile phase with the flow rate at 1.0 ml/min. The detection wavelength was 224 nm. Dissolution was de?termined by the basket method,using the 500 ml of 0.1 mol/L hydrochloric acid solution,pH 4.5 acetic acid buffer,water and pH 6.8 phosphoric acid buffer as dissolution media under the 50,75 and 100 r/min rotation speeds to select the dissolution condition. Re?sults This method had high specificity. The linear range for the quantitative determination was 20.74-155.58 μg/ml(r=1.0000), and the average recovery was 100.1%. The linear range for the determination of dissolution was 2.08-24.90μg/ml(r=0.9998),with the average recovery of 98.9%. The method of dissolution tests was established:0.1 mol/L hydrochloric acid solution was used as disso?lution medium and rotation speed was 50 r/min. The determined content and dissolution of three batches of capsules fulfilled the re?quirements. Conclusion The method is simple,accurate and reproducible for the determination of the content and dissolution of iso?phenylcyclopentylamine hydrochloride capsules.