Objective To establish a high-performance liquid chromatography(HPLC)method for content determination of oxycodone hydrochloride in Oxycodone Hydrochloride Prolonged-Release Tablets.Methods The chromatographic column was Agilent Eclipes XDB-C18 column(150 mm×4.6 mm,5 µm),the mobile phase was 1.1 g/L sodium heptane sulfonate solution(pH 2.0)-acetonitrile-methanol(750∶95∶155,V/V/V),the flow rate was 1.2 mL/min,the detection wavelength was 230 nm,the column temperature was 40℃,and the injection volume was 20 µL.Results The linear range of oxycodone was 0.047-189.920 µg/mL(R2 = 1.000 0,n = 6).The limit of quantification(LOQ)was 50.75 ng/mL.The RSDs of precision,repeatability,and stability test results were all lower than 2.0%.The average recovery of hydroxycodone was 99.72%with an RSD of 0.93%(n = 9).The contents of oxycodone hydrochloride in samples were 100.03%,100.82%,and 100.11%(n = 4),respectively.Conclusion The method is specific,robust,and accurate,which can be used for the content determination of oxycodone hydrochloride in Oxycodone Hydrochloride Sustained-Release Tablets.
维普
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