Study On The Structure And Quality Criterion Of Sibutramine Hydrochloride

Sibutramine Hydrochloride as drug for obesity functioning through central nerve system is a type of aminated compound. It's preparation works effectively on obesity patients, and has no or insignificant side effects.This article presents a systematical research on the quality control methodologies for the bulk material for the drug. The purpose of the research is to ensure the effectiveness and accuracy of the quality control process for the drug production.Since there is no contrast medium available for Sibutramine Hydrochloride, the research focus on conforming the structure of the studying sample, and conducted the comparative study of the drug specifications, to ensure its uniformity with the same type of the drugs on the international market.Through in depth study of the physical and chemical properties of Sibutramine Hydrochloride, the research established a complete system of quality criterion standards for the quality control processes for the production of the drug. Specifically, the research focuses on studies of systematical measuring methodology of relevant substances, organic remains and contents of the drug.During the process of establishing methodology for measuring Sibtramine Hydrochloride related substances, this articale used two methods-TLC and HPLC.In the researching of TLC, referenced the condition common used in thetype of organical base. The results indicate using the selected codition .sibutramine Hydrochloride and two main intermediates has good separation;but it can't detected the degradation products occurred by acid,furthmore ,one of the two main intermediatesis not sensitive to potassium iodobismuthate solution(dilute),So study on the related substances by HPLC .The separation and identifacation was performed on a hypersil -ODS column with methanol-water-triethylamine(85:15:0.01) concluding0.001 mol/L sodium heptanesulfonate (adjusting pH to 7.8 with acetic acid) as the mobile phase .and detected at 222nm wavelength.Using this condition . sibutramine Hydrochloride .two main intermediatesis and degradation products can be separated sufficiently .the reproducibility and precisite of the method was good .For the limitation test of residul solvent in acetone,ethyl acetate, isobutanol and toluene. A capillary Gcmethod was established DB-1 (25m X 0.32mm) as the analytical colum ;the temperature of the injection and detection ports is 250 °C ,the temperature column is procedure heating from 50°C to 200 °C as the velocity 30°C /min..the spilt ratio is 1:5.Sibutramine Hydrochloride is a type of aminated compound. During the research for the measuring methodology of its contents, the research used the classical titration in non-aqueous solvent and HPLC to conduct complete methodology verification. The results indicate that both methods are very effective and accurate used in quality control.Finally.this article study the stability of Sibutramine Hydrochloride.it is convenient for determinating the condition of store.The result indicated rbesides its related substances increasing so quickly under the high temperature(80 °C ), Sibutramine Hydrochloride is rather stable.so its should be stored at room temperature.