Abstract��
OBJECTIVE:To evaluate the dissolution of tramadol hydrochloride preparations from different manufactories. METHODS:The content of tramadol hydrochloride was determined by RP-HPLC with YWG-C18column(10��,4.6mm��250mm).The detection wavelength of the UV detector was at 215 nm.The mobile phase was composed of 0.05��mol��L-1potassium dihydrogen phosphate with 0.5% triethylamine (pH 2.5)-methanol(6��4).The flow rate was 1.5ml��min-1.To extract and compare the dissolution parameters of four kinds of samples,rotating basket method at the speed of 100 r��min-1was used.900ml of 0.1mol��L-1hydrochloric acid was used as dissloution medium for the sustained release tablets and capsules.900ml water was used instead for the common capsules and composite tablets. RESULTS:The dissolution rate of common capsules was the fastest with more than 85% within 15 minutes.The dissolution of the sustained release tablet and capsule were more than 80% within 16 hours and the composite tablet was 75% within 20 minutes.The sustained release capsule with the lot No.981003 was out of the sideline over the different time phases. CONCLUSIONS:Four kinds of the tramadol hydrochloride prepatation samples,except one lot of the sustained release capsule,were all come up to the standard of CHP(95) and Ministory of public health.
2000, Vol. 35 
