Determination of Meclofenoxate Content in Meclofenoxate Hydrochloride for Injection by DSC and 1H-NMR

Two simple and rapid analytical methods (DSC and 1H-NMR), are proposed for determination of meclofenoxate in meclofenoxate hydrochloride for injection. DSC thermogram is recorded without any sample pretreatment. The response linearity is ensured by linear determination factors R2, which is 0.9982. The recoveries of meclofenoxate hydrochloride in sterile powder for injection are from 98.3% to 102.3% (n = 3). The quantitative 1H-NMR is quick and simple to use. The quantitation of meclofenoxate is reproducible and the relative standard deviation is 1.0%. The accuracy of two methods is validated by comparison with the results obtained by HPLC. The results show that the two methods are capable of quantifying the content of meclofenoxate in meclofenoxate hydrochloride for injection.