Comparison Between Welch Xtimate® HPLC & A Well-known HPLC Column By Azithromycin API As Per USP.

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

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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