RP-HPLC Determination Of M-chlorobenzoic Acid In The Antidepressant Of Bupropion Hydrochloride

Bupropion Hydrochloride is a new antidepressant.There is m-chlorobenzoic acid during the degradation of Bupropion Hydrochloride,and there is m-chlorobenzoic acid in the production of Bupropion Hydrochloride.TLC is used to detect m-chlorobenzoic acid in USP,but this method has poor reproducibility and poor accuracy.Now TLC is gradually replaced by HPLC,which is used to detect the new drugas,but for some old productions,TLC wse used becase of lack of HPLC.Now HPLC has good LOD,LOQ and reproducibility,and ther is not TLC in our phamaceutical company,so HPLC is used to detect drugs,which can resolve some problems:1.It can shorten the testing cycle and avoid detection for delivery.2. It can avoid uncontrollable detection,which is requested for GMP.3. It can avoid unreliable detection becase of poor reproducibility.4. It can reduce costs.So a rapid convenient accurate and sensitive method is required to determine m-chlorobenzoic in Bupropion Hydrochloride.The study includes two parts.1,To establish a RP-HPLC method for the determination of m-chlorobenzoic acid in the antidepressant of Bupropion Hydrochloride in this paper. The chromatographic conditions: Mobile phase of Water-Acetonitrile-Trifluoroacetic acid (65:35:0.1) at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 235nm.The column temperature was 25℃.The injection volume is 20μL.The running time is 30min.we studied System suitability,System precision,Precision of the method,Intermediate precision,LOD and LOQ,Linearity and range,Solution stability,Durability and Specificity of this method.2,We determined three lots of Bupropion Hydrochloride by HPLC and TLC,and Compared the results by the two methods. The results show that RP-HPLC method is more sensitive than the TLC...