Overview
The organic impurity test of Azithromycin API is given in USP monograph. In this method, it was mentioned to use ‘4.6 mm x 25 cm; 5 µm packing L1’ HPLC column. From USP column database, we obtained that USP recommended to use Waters XTerra MS C18, 4.6 mm X 25 cm, 5µm HPLC column. The method equivalency study has been carried out for related substances of Azithromycin API USP to establish equivalency between Welch Xtimate® HPLC column andWaters XTerra HPLC Column. This report presents and discusses the results obtained in the equivalency study.
Columns
- Welch Xtimate® C18, (250 x 4.6)mm, 5µm
- Waters X-terra MS C18, (250 x 4.6), 5µm
Chromatographic system
| Column | 1. Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm 2. Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm |
| Wavelength | 210 nm |
| Flow rate | 1.0 mL/minute |
| Injection volume | 50 µL |
| Column temperature | 60°C |
| Auto Sampler temperature | 25°C |
Results
Column-1 : Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
Column-2 : Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
Conclusion
From the results of the equivalency study, the equivalency between the Welch Xtimate® HPLC column and Waters XTerra HPLC Column is proved. Hence a Welch Xtimate® HPLC Column can be used for related substances by HPLC of Azithromycin API as per USP.
Chromatograph of Blank
Fig 1: Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
Fig 2:Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
Chromatography of system suitability Solution
Fig 3:Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
Fig 4: Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
Chromatograph of Standard Solution
Fig 5: Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
Fig 6: Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
Chromatograph of Sample Solution
Fig 7：Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
Fig 8: Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
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