Evaluation On The Quality Of Generic Bupropion Hrdrochloride Sustained Release Tablets And Release Consistenc

Objective Through the optimization of the content,release and organic impurity determination method of bupropion hydrochloride sustained-release tablets in Chinese Pharmacopoeia,established a better quality control method to solve the problem of interference between impurities and auxiliary materials in the original UV method,To increase the control of known impurities,and through the generic drugs and the original research in the water,content,organic impurities and in vitro multi-media release curve and other key quality control projects to study the quality of generic drug evaluation,for its biological equivalent Sexual test work to provide data support for the preparation process optimization to provide technical support.Methods 1.To establish a method for determination of the content of Bupropion Hrdrochloride Sustained Release Tablets:Using high performance liquid chromatography,the HPLC system was Waters2695/2489 or equivalent UV detector,the column was Waters,C18,4.6×150mm,3.5μm,the column temperature was 30℃,the flow rate was 1.0mL/min,the mobile phase was Solution A:acetonitrile-trifluoroacetic acid-water(10:0.04:90)mixed solution,solution B:acetonitrile-trifluoroacetic acid-water(95:0.03:5)mixed solution,gradient elution.The detection wavelength was 226nm,the volume of sample was l0μL,the running time was 19min.The system applicability,linearity,accuracy,repeatability,intermediate precision,specificity and durability of the method were studied.2.To establish a method for determination of organic impurities in Bupropion Hrdrochloride Sustained Release Tablets:Using high performance liquid chromatography(HPLC)method,the HPLC system was Waters2695/2489 or equivalent UV detector,the chromatographic column was Agilent ZORBAX Bouns-RP,4.6×250mm,3.5μm,column temperature was 30℃ the flow rate was 1.0mL/min,the mobile phase was solution A:0.03%trifluoroacetic acid solution,solution B:acetonitrile,gradient elution,the detection wavelength was 226nm,the sample volume was 10μL,the operation time was 22min.The parameters such as system suitability,linearity,detection limit,accuracy,repeatability,intermediate precision,specificity and durability were studied.3.The establishment of Bupropion Hrdrochloride Sustained Release Tablets release test methods:The dissolution was determined by basket method,dissolution medium for 0.1N HCl,900mL,speed of 75 rpm,the temperature was 37.0±0.5℃,the sampling time was 2h,4h,8h,12h.The system suitability,linearity,accuracy,repeatability,intermediate precision,specificity,filtration and stability of the solution were investigated.4.The determination of water,content and organic impurities in the generic drug of bupropion hydrochloride and the original drug.The release degree of the generic drug of the bupropion hydrochloride sustained-release tablets and the original drug was investigated by using 0.1N hydrochloric acid,pH4.5 buffer solution,pH6.8 buffer solution and water as the dissolution medium.By calculating the difference factor f1 value and similarity factor f2 values to evaluate the similarity and quality consistency of the in vitro dissolution curves.Results 1.HPLC method was established for determination of the content of Bupropion Hrdrochloride Sustained Release Tablets,this method has high specificity and high precision,bupropion hydrochloride has good linearity in the concentration range of 0.3025-0.9075mg/ml,the original UV method is not the problem of high precision.2.HPLC method was established for the determination of organic impurities in Bupropion Hrdrochloride Sustained Release Tablets,the chromatographic conditions of gradient elution,impurity separation effect,short detection time,accurate and reliable method,good durability,strong specificity,high accuracy and good linearity.The organic impurities inspection is more suitable for Bupropion Hrdrochloride Sustained Release Tablets.3.A method of determination of the release of Bupropion Hrdrochloride Sustained Release Tablets,with accuracy and good linearity in the concentration range of 0.033～0.4125mg/ml,the method is simple,rapid,high sensitivity,and can effectively control the quality of drugs.4.(150mg&300mg specifications)and 1 batch of the original research drug content,organic impurities,moisture,the results show that the quality of both,and investigated the bupropion hydrochloride Sustained release tablets and the original drug in 0.1N hydrochloric acid,pH4.5 buffer solution,pH6.8 buffer solution,water 4 dissolution medium release,the results show that the four dissolution medium in the difference factor f1 values are less than 15,the similarity factor f2 values are higher than 50,indicating that the generic drug and the original drug in vitro dissolution curve has similarity.Conclusion 1.This study improved the quality control method of Bupropion Hrdrochloride Sustained Release Tablets content,organic impurities,dissolution,assay method was accurate and reliable,reproducible and can better control the quality of drugs.2.Bupropion Hrdrochloride Sustained Release Tablets generics and original drugs in vitro dissolution curves are similar,in line with the degree of dissolution test technology guidelines for oral solid preparations formulated by the state.Generic drugs and the original research in the water,content,organic impurities in the quality of the project level,the results showed that the quality of imidacid hydrochloride sustained-release tablets was good,and the quality of the original drug was high,which provided a reference for the bioequivalence test.