Li-qun Song
2006
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Journal
Chinese Journal of New Drugs
Abstract
Objective: To establish a HPLC method for determination of nalmefene hydrochloride for injection and its related substances. Methods: The HPLC method was set up as follows; a diamonsil C18 column (250 mm×4. 6 mm,5μm) , an eluate consisted of acetonitrile-0. 05 mol·L-1 phosphate buffer (20: 80) containing 0. 2% triethylamine (pH 4. 2±0. 02, adjusted with 85% phosphoric acid) with a flow rate of 1.0 mL·min-1 , and a detection wavelength at 210 nm. Results: A linearity of nalmefene concentration curve was within 21 - 126μg·mL-1 (γ= 1. 000). The detection limit was at 0. 2 ng and the RSD was 2% , and the average recovery was within 99.30% -99.42%. Conclusion: The HPLC method to determine nalmefene hydrochloride for injection and its related substances was achievable.