Method for determining content of compound amino acid injection
A technology of compound amino acid and determination method, which is applied in the field of content determination of compound amino acid injection, and achieves the effects of high accuracy, reduced analysis time and good repeatability
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Embodiment 1
[0055] Embodiment 1 compound amino acid injection content assay method
[0056]This embodiment is a method for determining the content of compound amino acid injection. The amino acid content in the compound amino acid injection containing tryptophan is separated and determined by one-time sample injection, including the following steps in sequence:
[0057] 1) Dosing:
[0058] Prepare a blank solution: adjust the pH of ultrapure water to 2.2 with 36.5% hydrochloric acid solution to obtain a blank solution;
[0059] Prepare a compound amino acid standard solution containing tryptophan: accurately weigh each amino acid reference substance (see Table 2 for the specific amount of each amino acid reference substance) and dissolve it in a 100ml measuring bottle with 50mL blank solution, dilute to volume, and prepare a compound formula Amino acid standard solution, wherein the concentration of each component of different amino acids is 100nmol / ml;
[0060] Preparation of the test ...
Embodiment 2-6
[0094] Embodiment 2-6 compound amino acid injection content assay method
[0095] Embodiments 2-6 are respectively the method for determining the content of the compound amino acid injection, the method of determination is the same as that of Example 1, the difference is that each process parameter in the process of determining the content of the compound amino acid injection is different, see Table 6 for details:
[0096] The list of each process parameter of table 6 embodiment 2-6
[0097]
[0098] The specific preparation ratio of the mobile phase used in the embodiment 2-6 is shown in Table 7-11:
[0099] The mobile phase preparation ratio list of table 7 embodiment 2
[0100]
[0101]
[0102] The mobile phase preparation ratio list of table 8 embodiment 3
[0103]
[0104] The mobile phase preparation ratio list of table 9 embodiment 4
[0105]
[0106] The mobile phase preparation ratio list of table 10 embodiment 5
[0107]
[0108]
[0109] Th...
Embodiment 7
[0115] Embodiment 7 method performance test
[0116] a1) Precision test
[0117] Precisely draw 1mL of compound amino acid standard solution, dilute it with hydrochloric acid solution (pH2.2) and set the volume to a 100ml volumetric flask, process 6 times in parallel, measure its content according to the assay method of Example 1, repeat 6 times, the test results are shown below surface.
[0118] The peak area result of table 13 precision test determination
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[0120]
[0121] It can be seen from Table 13 that the relative standard deviation value RSD is 0.63-2.00%, and the precision of the detection method is good.
[0122] a2) Accuracy test
[0123] According to the prescription quantity of this product, each amino acid content of preparation is high (120%), middle (100%), low (80%) of total 9 parts of solutions of prescription quantity respectively, measures its content by the assay method of embodiment 1, and calculates Recovery rate. The results of each ...
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Abstract
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