Method for evaluating uncertainty of inspection results of drug component contents calculated by using external standard method
A technology of component content and degree of certainty, which is applied in the field of evaluation of the uncertainty of drug component content test results by the external standard method, can solve the problem of deviation from the true value, and achieve a reasonable calculation effect
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Embodiment 1
[0038] This embodiment is a method for evaluating the uncertainty of drug content determination results in test materials for drug-related cases, which is applicable to the uncertainty evaluation of the results of gas chromatography or liquid chromatography detection and external standard method calculation of drug content. The drug components in the test materials of drug-related cases are extracted with solvents, analyzed by gas chromatography (GC) or liquid chromatography (HPLC), and quantified by external standard method.
[0039] Calculation formula of measurement results and establishment of mathematical model
[0040] The quantitative mathematical model for determining the content of drug components in drug samples by gas chromatography or liquid chromatography is:
[0041]
[0042] In the formula: w—the percentage of drug components in the sample, %;
[0043] V 1 - the volume of the sample solution initially fixed to volume, mL;
[0044] V 2 - from V 1 The volu...
Embodiment 2
[0149] An evaluation method for calculating the uncertainty of drug component content test results by an external standard method, comprising the following steps:
[0150] (1) Utilize gas chromatography to determine the drug component content in the drug sample, and establish a quantitative mathematical model as:
[0151]
[0152] In the formula: w—the percentage of drug components in the sample, %;
[0153] V 1 - The volume of the sample solution to be fixed for the first time, 20mL;
[0154] V 2 - from V 1 Pipette the sample solution volume, 1mL;
[0155] V 3 - put V 2 Add solvent volume when diluting, 20mL;
[0156] A——The average value of the chromatographic peak area of the drug components in the sample solution is 50;
[0157] A 0 - The average value of the chromatographic peak area of the drug components in the standard working solution is 50;
[0158] C o - the concentration of drug components in the standard working solution, 0.1mg / mL;
[0159] m—th...
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