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考察___

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 Kromasil C18 (250 mm×4.6 mm，5 μm)，流动相：乙腈（A）-水（磷酸调节pH至2.1）(B)，梯度洗脱\[0 min(12%A)→6 min(12%A) →14 min(50%A) →15 min(12%A) →22 min(12%A)\] 流速：1.0 mL•min-1 柱温：30 ℃ 检测波长：215 nm。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:HPLC methods were adopted，the chromatographic C18 column(250 mm×4.6 mm，5 μm) was used.The mobile phase consisted of acetonirrile(A)-water(adjusted to pH 2.1 with phosphoric acid)(B) with gradient elution\[0 min(12% A)→6 min(12% A) →14 min(50% A) →15 min(12% A) →22 min(12%A)\] and the flow rate was 1.0 mL•min-1.The detection wavelength was 215 nm.Results:The results showed that the content uniformity of 3 batches were A+1.80 S<15.0,the content uniformity of other 4 batches were A+1.80 S>15.0，showed markedly difference(p<0.01).Conclusion:It can be used to determine the content uniformity of compound paracetamol and diphenhydramine hydrochloride tablets.