Method for determining content of impurities contained in etamsylate medicine and content of main medicine thereof

[0054] Example 1

[0055] Limits of detection and limits of quantitation

[0056] Specifically include the following steps:

[0057] S11, configure each impurity mother liquor;

[0058] Accurately weigh 20 mg each of impurities A, B, C, D, and P, put them in 100ml measuring bottles, dissolve them with diluent, dilute to the mark and shake well;

[0059] Accurately weigh 20 mg each of impurities L and J, put them in a 100 ml measuring bottle, dissolve them with 1 ml of methanol first, then dissolve them with a diluent and dilute to the mark and shake well;

[0060] Accurately weigh 10 mg of ethylamine phensulfame, put it in a 10 ml measuring bottle, dissolve it with diluent and dilute to the mark and shake well.

[0061] S12, configuring each detection limit solution;

[0062] Accurately measure 0.25ml each of the above-mentioned impurity P, J, L, A, B mother liquor, 0.5ml of impurity C mother liquor, 0.1ml of impurity D mother liquor, and 1ml of ethylamine sulfamate mother li

[0070] Example 2

[0071] Detection of Standard Curve

[0072] Specifically include the following steps:

[0073] S21, configuring the mother liquor of each impurity reference substance;

[0074] Accurately weigh 20 mg each of impurities A, B, C, D, and P, put them in 100ml measuring bottles, dissolve them with diluent, dilute to the mark and shake well;

[0075] Precisely weigh 20 mg each of impurities L and J, put them in a 100ml measuring bottle, first dissolve them with 1ml methanol, then dissolve them with diluent and dilute to the mark and shake well;

[0076] Accurately weigh 10 mg of ethylamine phensulfate and put it in a 50 ml measuring bottle, dissolve it with a diluent and dilute to the mark and shake well.

[0077] S22, configure each linear solution;

[0078] Linear solution 1: Accurately measure 1.0ml of the mother solution of each impurity reference substance and put it in a 100ml measuring bottle, dissolve it with a diluent and dilute to the mark and shake wel

[0092] Example 3

[0093] Accuracy test

[0094] Specifically include the following steps:

[0095] S31, configuring each impurity mother liquor;

[0096] Accurately weigh 20.0mg each of impurities A, B, C, D, and P, put them in 100ml measuring bottles, dissolve them with diluent and dilute to the mark and shake well;

[0097] Accurately weigh 20.0 mg of impurities L and J, put them in 100 ml measuring bottles, dissolve them with 1 ml of methanol first, then dissolve them with diluent and dilute to the mark and shake well.

[0098] S32, configure the recovery rate impurity mixed solution;

[0099] 50% impurity mixed solution: accurately measure 0.25ml of the above-mentioned impurity mother liquors, put them in a 100ml measuring bottle, dilute to the mark with a diluent, and shake well to obtain a 50% impurity mixed solution;

[0100] 100% impurity mixed solution: accurately measure 0.5ml of the above-mentioned impurity mother liquors, put it in a 100ml measuring bottle, dilut