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目的:测定复方氨酚苯海拉明片中盐酸苯海拉明及盐酸麻黄碱含量均匀度。方法:采用HPLC法,色谱柱:迪马Kroma-silC18(250mm×4.6mm,5μm),流动相:乙腈(A)-水(磷酸调节pH至2.1)(B),梯度洗脱[0min(12%A)→6min(12%A)→14min(50%A)→15min(12%A)→22min(12%A)];流速:1.0mL.min-1;柱温:30℃;检测波长:215nm。结果:所测定的7批样品中,除有3批样品含量均匀度为A+1.80S<15.0,其余含量均匀度为A+1.80S>15.0,有显著性差异(p<0.01)。结论:本法可用于该制剂的含量均匀度检查。
Objective: To determine the content uniformity of diphenhydramine hydrochloride and ephedrine hydrochloride in compound paracetamol and diphenhydramine hydrochloride tablets. Methods: The HPLC method was adopted. The column was Dima Kroma-silC18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-water (phosphoric acid adjusted to pH 2.1) % A) → 6 min (12% A) → 14 min (50% A) → 15 min (12% A → 22 min A)]; flow rate: 1.0 mL · min -1; : 215nm. Results: Among the seven batches of samples, the content uniformity of the three batches of samples was A + 1.80S <15.0, the other content uniformity was A + 1.80S> 15.0, with significant difference (p <0.01). Conclusion: This method can be used for the content uniformity of the preparation.