Study On Irbesartan And Hydrochlorothiazide Compound Formulation

Objective:Investigate the preparation and process of irbesartan and hydrochlorothiazide tablets, and establish the analysis method to control quality. Method:Make an optimization for formulation of this tablet adopting single factor test, regarding the parameter of dissolution degree (Td) as index. And to investigate the influence of different excipients to the dissolution of irbesartan and hydrochlorothiazide respectively; Use HPLC method to determine the content, dissolution, the related substances and the stability of the compound tablet. Result: The best formulation composition of this tablet contained irbesartan150mg, hydrochlorothiazide12.5mg, PVPP2.6mg, Latose.H2O84.5mg, PVPK307.8mg, MS2.6mg. In this paper, the method used for detecting the content and dissolution was: ZORBAX Eclipse XDB-C18(4.6×150mm,5μm) column was used, acetonitrile-0.02mol/L monopotassium phosphate (phosphoric acid adjust to pH3.0) as mobile phase, colume temperature was25℃, the flow rate was1.0mL/min, the detection wavelength was263nm. The peak area (A) with the standrad series of concentrations (C) linear regression, the linear coefficients are both about0.9999, results show that the linear ranges were1.25μg/ml～18μg/ml for hydrochlorothiazide, and15μg/ml～210μg/ml for irbesartan. Adopting the gradient elution of the same colume, colume temperature and flow rate,220nm as the detection wavelength, acetonitrile-0.02mol/L monopotassium phosphate (phosphoric acid adjust to pH3.2) as mobile phase to detect the related substance, and the reslut shows the mehod has good specificity, the content of related substance known were controlled under0.01%. Conclution:The formulation of the tablet is reasonable, the preparation technology is feasible; the HPLC method established is rapid, simple and reliable, and so it can be used to control the quality of this compound formulation; and the stability study indicated the tablet prepared is quite stable.