相关物质HPLC检查中，关于梯度程序的： 1.as mobile phase at a flow rate of 1.5ml/min a double isocratic programme using the following conditions. 红体字该如何理解？
2.The test is not valid unless the resolution between the peaks corresponding to verapamil and verapamil impurity I is at least 5.0 and verapamil impurity M elutes from the column. 这个5.0是什么意思？没看明白
呵呵，刚忘了一句，现补充下： 4.Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b)
2.The test is not valid unless the resolution between the peaks corresponding to verapamil and verapamil impurity I is at least 5.0 and verapamil impurity M elutes from the column. 这个5.0是维拉帕米色谱峰和杂质I色谱峰之间的分离度。这句话的意思是说：这个实验有效必须满足两个条件：1.维拉帕米色谱峰和杂质I色谱峰之间的分离度不低于5.0；2.杂质M应从色谱柱上洗脱。
In the chromatogram obtained with the test solution: the area of any peak, apart from the principal peak, is not greater than the area of the principal peak in the chromatogram obtained with reference solution (b) (0.1 per cent); 供试品溶液色谱图中，除主峰外的任何色谱峰的峰面积应不大于对照溶液（b）色谱图中主峰的峰面积（0.1％）。－－即单个杂质的限度为0.1％。
the sum of the areas of the peaks, apart from the principal peak, is not greater than three times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.3 per cent). （供试品溶液色谱图中）除主峰外的任何色谱峰的峰面积之和应不大于对照溶液（b）色谱图中主峰峰面积的3倍（0.3％）。－－即总杂质的限度为0.3％。
Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with reference solution (b). （供试品溶液色谱图中）若有任何色谱峰的峰面积小于对照溶液（b）色谱图中主峰峰面积的十分之一，则忽略不计。－－即含量低于0.01％的杂质可忽略不计。
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