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）

Mobile Phase

Formic acid: dicyclohexane: water = 1:1:998

Column Temperature

30℃

Detector

Injection Volume

20μL

Flow Rate

1.0 ml/min

Detect wavelength

210 nm

Elution procedure

Time (min)	Formic acid: dicyclohexane: water = 1:1:998
0	100%
20	100%

Note

Chromatogram and Data:

1) System suitability solution Analytical spectrum at 30℃ column temperature:

Serial number	Peak name	Retention time (min)	*Peak Area(mAUmin)**	S/N	Relative peak area(%)	Resolution (EP)	Number of plates(EP)	Asymmetry (EP)
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(mAUmin)**	S/N	Relative peak area(%)	Resolution (EP)	Number of plates(EP)	Asymmetry (EP)
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

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.