Ultisil LP-C18 Octreotide Acetate Injection Analysis Method Development Report
Test Report
Chromatography conditions:
Column |
Welch Ultisl® LP-C18（4.6×250mm，5μm) |
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Mobile Phase |
Phase A: Tetramethylammonium hydroxide solution (pH5.4): Acetonitrile = (9:1) Phase B: Tetramethylammonium hydroxide solution (pH5.4): Acetonitrile = (4:6) |
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Column Temperature |
35℃ |
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Detection wavelength: |
225 nm |
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Detector |
UV （210nm） |
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Flow Rate |
1.0 ml/min |
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Injection Volume |
20 μL |
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Elution program |
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Note |
/ |
Chromatogram and Data:
1. System adaptability solution map:
Retention time |
Area (mAU*min) |
Peak Height (mAU) |
Relative peak area(%) |
Resolution |
Number of plates (EP) |
S/N |
|
des-Thy-ol8-octreotide |
13.115 |
3.861 |
20.532 |
8.78 |
6.99 |
32573 |
1644.2 |
Octreotide Acetate |
15.270 |
40.222 |
184.534 |
91.24 |
N.a. |
34772 |
14777.5 |
SUM |
|
44.084 |
|
100.00 |
0.00 |
|
|
2. Octreotide acetate injection map
Retention time |
Area (mAU*min) |
Peak Height (mAU) |
Relative peak area(%) |
Resolution(EP) |
Number of plates (EP) |
S/N |
|
Unknown impurity |
14.137 |
0.043 |
0.241 |
0.10 |
1.07 |
29645 |
4.4 |
des-Thy-ol8-octreotide |
14.477 |
0.359 |
1.849 |
0.79 |
9.70 |
35520 |
33.3 |
Octreotide Acetate |
17.700 |
44.964 |
190.736 |
99.11 |
N.a. |
38797 |
3438.2 |
SUM |
|
44.084 |
|
100.00 |
0.00 |
|
|
Conclusion:
Under these HPLC conditions, Welch Ultisl® LP-C18（4.6×250mm，5μm) can meet the detection requirements.