In Vitro Dissolution Consistency Evaluation Study of Generic Aminophylline Tablets with Reference Preparations
Objective:To establish a dissolution assay method for Aminophylline tablets,and to investigate the similarity of the in vitro dissolution profiles of 10 domestic formulations and the reference formulation in 4 dissolution media as well as the inter-batch and intra-batch homogeneity of 10 batches of the reference formulation.Methods:The second method of Chinese Pharmacopoeia dissolution assay was adopted,and 900 mL of pH 1.2 buffer,pH 4.0 buffer,pH 6.8 buffer and water were used as the dissolution medium at a rotational speed of 50 revolutions per minute;and the dissolution amount at each time point was determined by high performance liquid chromatography(HPLC)on a column of Elite BDS(5 μm,4.5×250 mm),with a mobile phase of methanol-0.12％pentanes The mobile phase was methanol-0.12％sodium pentanesulfonate solution(20∶80)(pH adjusted to 2.9±0.1 with glacial acetic acid),the detection wavelength was 254 nm,and the injection volume was 20 μL.Results:The linearity,precision,and recovery of the assay method met the requirements,and the dissolution amount of the 10 batches of the reference preparations was in the range of 27％～33％at 5 min,and the cumulative dissolution amount at 30 min reached 100％.The dissolution amount of the 10 batches of reference preparations was in the range of 27％～33％at 5 min,and the cumulative dissolution amount reached 100％at 30 min.Conclusion:The established method is proprietary and accurate,and can be used for the determination of the in vitro dissolution profile of Aminophylline tablets.10 batches of reference preparations had good inter-batch and intra-batch homogeneity,and the domestic preparations of 10 manufacturers had sudden release in 4 dissolution media,which differed from that of the reference preparations in the in vitro dissolution profiles.
万方数据
维普
