Determination of disodium edetate in nalmefene hydrochloride injection by HPLC / 国际药学研究杂志

ABSTRACT

Objective To establish a high performance liquid chromatography(HPLC)method for the determination of disodi-um edetate(EDTA-2Na)in nalmefene hydrochloride injection. Methods Content of EDTA-2Na in nalmefene hydrochloride injection was determined by HPLC. C18 Column was used. The mobile phase consisted of 0.3%tetrabutylammonium hydroxide solution-water-acetonitrile(204535)with a flow rate of 1.0 ml/min,and the detection wavelength was 254 nm. The column temperature was 30℃and the injection volume was 20μl. Results The quantification limit and detection limit were 0.199 and 0.060μg/ml,respectively;the linear equation for the disodium edetate was Y=10.125X-0.216,and the calibration curves were linear within the range of 2.4593~7.3780 μg/ml(r=1.000). Each concentration of the average recovery was between 98~102%(n=9)(RSD%=0.58%). Conclusion The method can be used for the determination of EDTA-2Na in nalmefene hydrochloride injection,which is convenient,fast,sensitive and reproducible,with good precision,specificity and accuracy.