Comparison between Welch Xtimate® HPLC & a well-known HPLC Column by Azithromycin API as per USP.

Published by News Editor on

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

  1. Welch Xtimate® C18, (250 x 4.6)mm, 5µm
  2. Waters X-terra MS C18, (250 x 4.6), 5µm

Chromatographic system

Column1. Welch Xtimate C18 (250 mm x 4.6 mm), 5 µm
2. Waters X-terra MS C18, (250 mm x 4.6 mm), 5µm
Wavelength210 nm
Flow rate1.0 mL/minute
Injection volume50 µL
Column temperature60°C
Auto Sampler temperature25°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

If you have any problem or require further information, please contact info@welchmat.com.


0 Comments

Leave a Reply

Avatar placeholder

Your email address will not be published. Required fields are marked *