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目的 :建立清脑片中主要成分盐酸吡硫醇及地西泮含量测定的方法。方法 :色谱柱为 Waters Nova- Pak C1 8(4 ︼m,3.9mm× 15 0 mm) ,流动相 :甲醇∶水∶三乙胺∶冰醋酸 (6 5∶ 35∶ 0 .2∶ 0 .15 ) ,流速 0 .6 m l/ min,检测波长 2 30 nm。结果 :盐酸吡硫醇浓度为 16～ 40 0︼g/ m l,地西泮浓度 2～ 5 0︼g/ ml,峰面积 (A)与浓度 (c)均呈良好的线性关系 ,回归方程分别为 :c=9.96 2× 10 - 5 A+ 0 .831(r=0 .9999)及 c=2 .5 83× 10 - 5 A + 0 .175 (r=0 .9998)。平均回收率分别为 99.36 % ,RSD=1.0 8%(n=6 )及 99.2 8% ,RSD=1.34% (n=6 )。结论 :本法操作简便 ,重复性好 ,结果准确 ,可作为该制剂的质量控制方法。
Objective: To establish a method for the determination of the content of pyrithiol hydrochloride and diazepam in Qingnao Tablet. Methods: The column was Waters Nova Pak C1 8 (4 μm, 3.9 mm × 150 mm). The mobile phase consisted of methanol: water: triethylamine: glacial acetic acid (65:35:20:15:15 ), Flow rate 0.6 ml / min, detection wavelength 230 nm. Results: The concentration of pyrithione hydrochloride was 16 ~ 40 0︼g / ml and the concentration of diazepam was 2 ~ 5 0︼g / ml. The peak area (A) and concentration (c) showed a good linear relationship. As follows: c = 9.96 2 × 10 -5 A +0.831 (r = 0.9999) and c = 2.583 × 10 -5 A +0.175 (r = 0.9998). The average recoveries were 99.36%, RSD = 1.08% (n = 6) and 99.28%, respectively, with RSD = 1.34% (n = 6). Conclusion: This method is simple, reproducible, accurate and can be used as a quality control method for this preparation.