Ultisil ODS-3 - Yangtze River Pharmaceutical Lactic Acid Post-sales Analysis Method Validation Report
Test Report
Chromatography conditions:
Column |
Welch Utisil ODS-3（4.6×150mm,5μm） |
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Mobile Phase |
Formic acid: dicyclohexane: water = 1:1:998 |
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Column Temperature |
30℃ |
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Detector |
UV |
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Injection Volume |
20μL |
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Flow Rate |
1.0 ml/min |
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Detect wavelength |
210 nm |
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Elution procedure |
|
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Note |
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Chromatogram and Data:
1) System suitability solution Analytical spectrum at 30℃ column temperature:
Serial number |
Peak name |
Retention time (min) |
Peak Area(mAU*min) |
S/N |
Relative peak area(%) |
Resolution |
Number of plates(EP) |
Asymmetry |
1 |
Acetic acid |
3.577 |
12.081 |
0.4 |
44.11 |
9.55 |
7493 |
0.89 |
2 |
Lactic acid |
6.202 |
15.308 |
72.2 |
55.89 |
N.a. |
4129 |
1.98 |
Sum |
|
27.389 |
|
100.00 |
9.55 |
|
|
2) System suitability solution Analytical spectrum at 40℃ column temperature:
Serial number |
Peak name |
Retention time (min) |
Peak Area(mAU*min) |
S/N |
Relative peak area(%) |
Resolution |
Number of plates(EP) |
Asymmetry |
1 |
Acetic acid |
3.137 |
11.893 |
0.2 |
44.52 |
7.47 |
4678 |
0.81 |
2 |
Lactic acid |
5.297 |
14.821 |
124.7 |
55.48 |
N.a. |
2851 |
1.49 |
Sum |
|
26.714 |
|
100.00 |
7.45 |
|
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Conclusion:
The system suitability solution was analyzed under these chromatographic conditions using Welch column Ultisil ODS-3 (4.6×150mm, 5μm). The resolution between sodium lactate and sodium acetate was 9.55, and the tailing factor of the sodium lactate peak was 1.98, both meeting the analysis requirements.