高效液相色谱法测定盐酸羟考酮缓释片中盐酸羟考酮含量

Content Determination of Oxycodone Hydrochloride in Oxycodone Hydrochloride Prolonged-Release Tablets by HPLC

目的建立测定盐酸羟考酮缓释片中盐酸羟考酮含量的高效液相色谱法。方法色谱柱为Agilent Eclipes XDB-C_(18)柱(150 mm×4.6 mm,5μm),流动相为1.1 g/L庚烷磺酸钠溶液(pH 2.0)-乙腈-甲醇(750∶95∶155,V/V/V),流速为1.2 mL/min,检测波长为230 nm,柱温为40℃,进样量为20μL。结果羟考酮的质量浓度在0.047~189.920μg/mL范围内与峰面积线性关系良好(R^(2)=1.0000,n=6);定量限为50.75 ng/mL;精密度、重复性、稳定性试验结果的RSD均小于2.0%;平均回收率为99.72%,RSD为0.93%(n=9)。样品中盐酸羟考酮的含量分别为100.03%,100.82%,100.11%(n=4)。结论该方法专属性强、耐用性好、回收率高,可用于盐酸羟考酮缓释片中盐酸羟考酮的含量测定。

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-C_(18) column(150 mm×4.6 mm,5μm),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 20μL.Results The linear range of oxycodone was 0.047-189.920μg/mL(R^(2)=1.0000,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.