Study On Quantity Of Oprinone Hydrochloride

Olprinone hydrochloride is a typical selective phosphodiesteraseⅢ inhibitor,it is used for the treatment of congestive heart failure through the former mechanism of the heart to improve the hemodynamic parameters and exercise tolerance.The drug can enhance the myocardial contraction,dilation the blood vessel and improve the heart insufficiency,it has a significant effect on the reduction of cardiac morbidity and the reduction of mortality rates.Clinical validation proved that olprinone hydrochloride didn’t increase myocardial oxygen consumption,but increase Cardiac output,it has high efficiency than catecholamines in improving myocardial energy.Foreign research demonstrate that olprinone hydrochloride can be used for apoplexy,protecting liver and spleen and relaxing smooth muscle.In accordance with《the State Provisions for Drug Registration》,the bulk drug of Olprinone hydrochloride belongs to a drug of 3.1,and has not imported in China.This paper carried out the qualitative research,quality control and stability of the bulk drug of Olprinone hydrochloride.The main contents include two parts as follows(1)The instrumental method(UV and HPLC)and chemical method was adopted for identification(related substances and residual solvent)of Olprinone hydrochloride,the HPLC method was established for determining the content of the Olprinone hydrochloride substances,The chromatographic separation condition were:The separating column was a 250 × 4.6 mm Thermo C18 with 5 μm particles.,the mobile phase was ammonium dihydrogen phosphate(0.02 mol/L,pH value adjusted to 3.0 with phosphoric acid)-acetonitrile(90:10);and the flow rate was 1.0 mL/min,the detection wavelength was set at 215nm.Validation tests were done for the method and the results shown that the established method had good precision(RSD = 0.5%)and the linear regression equation was(Y =328387.04781 X + 545018.94806,R = 0.99998).(2)Stability tests were carried out for different batches contains accelerated test and samples on long-term test.The accelerated test data demonstrated that the samples were stable in the situation of 40℃ and RH 75%for 6 months.The long-term test data showed that the samples were stable on long term at room tempreture.