Determination of the Impurities in Morphine Sulfate and Morphine Sulfate Sustained-release Tablets by Ultra High Performance Liquid Chromatography
Objective:To Establish an Ultra High Performance Liquid Chromatography(UHPLC)method to determine impurities in morphine sulfate and morphine sulfate sustained-release tablets.Methods:ACQUITY UPLC HSS C18(100 mm × 2.1 mm,1.8 μ m)chromatographic column was used to determine,with 0.101％sodium heptane sulfonate solution(adjusted to pH 2.6 with 50％phosphoric acid solution)and methanol as the mobile phase for gradient elution,column temperature at 35 ℃,flow rate of 0.3 mL·min-1,and detection wavelength of 230 nm.Results:This method achieved good separation between codeine phosphate(impurity A),pseudomorphine(impurity B),oripavine(impurity C),10-hydroxymorphine(impurity D),morphine ketone(impurity E),morphine nitrogen oxide(impurity F),and 14-hydroxymorphine ketone(impurity G,genotoxic impurity),as well as other adjacent impurities.The use of UHPLC greatly reduced analysis time and the consumption of organic solvent methanol,making it more green and environmentally friendly.Conclusion:This method is the first to simultaneously separate all known impurities of morphine sulfate and 14-hydroxymorphone ketone under UHPLC conditions with good specificity,and the correction factor method is used to accurately quantify the 7 known impurities in the API and the preparation,and the related substances in morphine sulfate and its preparation morphine sulfate sustained-release tablets can be determined at the same time,which provides a technical basis for the selection of raw materials and the control of the preparation process.
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