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采用归一化法将药物浓度放大到100倍,在高效液相色谱仪上,测定沙美特罗羟基萘甲酸盐中的杂质。实验结果:5批样品中杂质百分含量为0.2988%±10.017%,小于1.0%。符合药典规定原料药一般杂质检查的限度。
The normalization method was used to amplify the drug concentration to 100 times and the impurity in salmeterol xinafoate was determined on a high performance liquid chromatograph. Experimental results: 5 batches of samples in the percentage of impurities is 0.2988% ± 10.017%, less than 1.0%. In line with Pharmacopoeia general impurity inspection limits.