Establishment of dissolution test method of isoniazid tablets and evaluation of dissolution profiles / 药物评价研究

ABSTRACT

Objective To establish a method for determining the dissolution of isoniazid tablet in vitro and evaluate the dissolution profiles.Methods The paddle method was used for the dissolution test and the rotation rate was set at 50 r/min.The hydrochloric acid solution (pH 1.2),acetate buffer solution (pH 4.5),phosphate buffer solution (pH 6.8) and water (900 mL) were used as the dissolution media.HPLC was used for the determination of dissolution quantity.Results There was a good linear relationship between the quality concentration of i soniazid and peak area in the range of 0.1981-0.9904μg (r =0.9993).The average recovery was 100.2％.Precision,reproducibility,and specificity tests were good.Among the determination of 16 manufactures,the dissolution profiles in water of four manufactures were not similar with Sandoz reference preparation.Conclusion The HPLC method is simple.The accuracy and specificity of determination of isoniazid dissolution are improved.There is significant difference in the dissolution profiles between different manufactures.The method can be used for the determination of dissolution curves for isoniazid tablets.