HPLC法同时测定盐酸奈福泮萘普生胶囊中2种成分的含量

目的 建立同时测定盐酸奈福泮萘普生胶囊中盐酸奈福泮和萘普生含量的高效液相色谱方法.方法 采用Apollo C18色谱柱,以庚烷磺酸钠溶液-乙腈(53:47)为流动相,流速为1.0 mL·min-1,检测波长为215 nm.结果 盐酸奈福泮浓度在15.8～47.5 μg·mL-1范围内与峰面积线性关系良好(r=0.9997),平均回收率为99.43％,RSD为1.31％(n=3)；萘普生在54.7～164.2 μg·mL-1范围内线性关系良好(r=0.9999),平均回收率为99.72％,RSD为0.80％(n=3).结论 该方法操作简便,结果准确,精密度高,可用于控制盐酸奈福泮萘普生胶囊的质量.

Content Determination of Nefopam Hydrochloride and Naproxen in Nefopam Hydrochloride Naproxen Capsules by HPLC

Objective To establish an HPLC method for content determination of nefopam hydrochloride and naproxen in Nefopam Hydrochloride Naproxen Capsules.Methods Apollo C18 column was used with the mobile phase of sodium heptanesulfonate solution-acetonitrile（53∶47）.The flow rate was 1.0 mL·min-1 and the detection wavelength was at 215 nm.Results The linear range of nefopam hydrochloride was 15.8～47.5 μg·mL-1（r=0.9997）;the average recovery was 99.43%,RSD=1.31%（n=3）.The linear range of naproxen was 54.7～164.2 μg·mL-1（r= 0.9999）;the average recovery was 99.72%,RSD=0.80%（n=3）.Conclusion The method is simple,convenient,accurate,and can be used for quality control of Nefopam Hydrochloride Naproxen Capsules.