盐酸美普他酚片质量标准的研究

Study on the quality standard of Meptazinol hydrochloride Tablets

目的:以反相高效液相色谱法(RP-HPLC)测定盐酸美普他酚片中盐酸美普他酚的含量,并对其进行检查、鉴别等方面的考察,制订盐酸美普他酚片剂的质量标准。方法:采用ODS Hypersil C18(4.6 mm×250 mm,5μm);以甲醇-0.05 mol/L醋酸铵缓冲液(50∶50)为流动相;流速:1.0 ml/min;检测波长:275 nm。结果:被测组分的线性关系良好,回收率满意。结论:本文建立的质量标准能很好地控制成品质量。

Objective： To define the quality standard of Meptazinol hydrochloride Tablets by RP-HPLC and observe the Tablets with examination and discrimination.Methods： The content of Meptazinol hydrochloride Tablets was determined by HPLC.The analysis was carried on ODS Hypersil C18（4.6 mm×250 mm,5 μm） with the mobile phase of methanol-0.05 mol/L am-monium acetate（50∶50） and eluted the detection wavelength at 275 nm.Results： A good linearity was shown with the de-tection method of content.The average recovery rate was contentment.Conclusion： It can be used for the quality control of products.