Vinpocetine Injection Quality Standard Upgrade

Vinpocetine,a semi-synthetic derivative of indole alkaloid,is isolated by the oleaster vincamajor(vincaminor),which is widely used in ischemic cerebrovascular diseases.Degradation of vinpocetine injection impurity research,mainly is the impurity ethyl amine(vincristine ethyl),impurities B(apovincamine),impurity C(methoxy vinpocetine)and impurity D(hydrogen vinpocetine),and about the impurities A,for the product of the degradation of another major impurities F(alprovinamic acid)were not studied.Although vinpocetine is half synthetic product,the chiral template inheritance from natural product TabeR,Sonine in the proceS,S of preparation of vincamine and vinpocetine,which is not involved in the molecular structure of vinpocetine chiral center,in the proceS,S of vinpocetine injection production and storage degradation reaction does not involve to center,so the main medicine of vinpocetine in optical configuration should not be changed.However,due to the increasingly strict requirements of national policies on the control of impurities in drugs,the existing literature fails to confirm the safety characteristics of three chiral isomeR,S of vinpocetine.Therefore,the objective of this research is to establish a quality control method of vinpocetine injection for degrading impurities F(alpovinamic acid)and optical isomer impurities(S,R-vinpocetine,R,R-vinpocetine and R,S-vinpocetine).Impurity F detected method,column is C18,15.4 g ammonium acetate diS,Solves in 1000mL water(adjust pH to 2.0 with glacial acetic acid)as mobile phase A,acetonitrile as mobile phase B.263 nm was the ultraviolet wave,column temperature was 35? and flow rate was 1.0 mL/min.The isomeR,S were detected by CHIRALPAK(?)IG-3(4.6mm×250mm,3?m)column with ammonium phosphate solution(0.02mol/L ammonium dihydrogen phosphate and 0.02mol/L diammonium hydrogen phosphate)acetonitrile(35:65=V/V)as mobile phase,detection wavelength 228nm,flow rate 0.4mL/min.