高效液相色谱法测定盐酸奈福泮萘普生胶囊中盐酸奈福泮含量

目的 建立测定盐酸奈福泮萘普生胶囊中盐酸奈福泮萘含量的高效液相色谱法.方法 色谱柱为AgilentC18柱(250 mm×4.6mm,5 μm),以庚烷磺酸钠溶液(取庚烷磺酸钠2.02g,加水900mL使溶解,加三乙胺2mL,用稀磷酸调节pH=3.0,加水至1 000mL)-乙腈(60:40)为流动相,流速为1.0 mL/min,检测波长为215 nm.结果 盐酸奈福泮萘质量浓度在10.16 ～ 101.60 μg/mL范围内与峰面积线性关系良好(r=0.9999),平均回收率为100.23％,RSD为0.83％(n=6).结论 该方法简便、准确,可用于控制盐酸奈福泮萘普生胶囊的质量.

Determination of Nefopam Hydrochloride in Nefopam Hydrochloride Naproxen Capsules by HPLC

Objective To develop a HPLC method for determining nefopam hydrochloride in Nefopam Hydrochloride Naproxen Capsules. Methods The Agilent C18 column （150 min×4.6 ram, 5 μm） was used with the mobile phase of sodium heptanesulfonate solution （taking sodium heptanesulfonate 2.02 g, adding 900 mL water for dissolution, adding triethylamine 2 mL,adjusting pH =3.0 with dilute phosphoric acid, and adding water to 1 000 mL）-aeetonitrile （60：40）. The flow rate was 1 0 mL/min and the detecting wavelength was at 251 nm. Results The linear range of nefopam hydrochloride was 10. 16 - 101.60μg/mL. The average recovery rate was 100.23%, RSD =0. 83% （r^2=0. 999 9, n =6）. Conclusion This method is simple and accurate, and can be used for controlling the quality of Nefopam Hydrochloride Naproxen Capsules.