Determination of the Correction Factor for Dinalmefene Hydrochloride in Nalmefene Hydrochloride Injection

Objective: To calculate the detection correction factor for the impurity, that is, the dinalmefene hydrochloride in nalmefene hydrochloride injection. Methods: High performance liquid chromatography (HPLC) is used to analyze the impurities of nalmefene hydrochloride easily produced during storage, and the impurity is determined and correction factor is calculated for the known the dinalmefene hydrochloride. According to the standard curve method, the sample concentration is selected between the detection limit and the limit of quantification, and the standard curve is prepared. The correction factor is then calculated according to the slope of the standard curve. Results: finally, the correction factor for dinalmefene hydrochloride is 0.22. Conclusions: the correction factor calculated by the standard curve method is accurate and reliable, and can be used for impurity detection of nalmefene hydrochloride injection.