Method of evaluating uncertainty of test results of drug components by working curve 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, and can solve problems such as deviation from the true value
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Embodiment 1
[0036] 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 the standard curve method.
[0037] Calculation formula of measurement results and establishment of mathematical model
[0038] The quantitative mathematical model for determining the content of drug components in drug samples by gas chromatography or liquid chromatography is:
[0039]
[0040] In the formula: w—the percentage of drug components in the sample, %;
[0041] V 1 - the volume of the sample solution initially fixed to volume, mL;
[0042] V2 - from V 1 The volume of the sample solution pipetted in, mL;
[0043] V 3 - put V 2 The volume of solvent added during dilution, mL;
[0044] C—concentration of drug components in the sample solution, mg / mL;
[0045] m—the weighing weight of the drug sample used for determination, mg.
[0046] Uncertainty source analysis
[0047] ...
Embodiment 2
[0154] An evaluation method for calculating the uncertainty of drug component content test results by a standard curve method, including
[0155] Next steps:
[0156] Step one, establish gas chromatography or liquid chromatography to determine the content of drug components in drug samples
[0157] The quantitative mathematical model is:
[0158]
[0159] In the formula: w—the percentage of drug components in the sample, %;
[0160] V 1 - The volume of the sample solution to be fixed for the first time, 20mL;
[0161] V 2 - from V 1 Pipette the sample solution volume, 1mL;
[0162] V 3 - put V 2 Add solvent volume when diluting, 20mL;
[0163] C - the concentration of drug components in the sample solution, 0.164, 0.166mg / mL;
[0164] m——Weighing weight of the drug sample used for determination, 99.50, 100.50 mg.
[0165] Step 2, analyzing sources of uncertainty includes: measuring the uncertainty u introduced by repeatability 0 , derived from the uncertainty u(...
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