Objective

The related substances test of Paracetamol API is given in European Pharmacopoeia monograph. In this method, it was mentioned to use ‘end-capped solid core octadecylsilyl silica gel, 0.10m x 2.1 mm; 2.7 µm’ HPLC column. This method equivalency study has been carried out for related substances of Paracetamol API as per EP monograph to establish equivalency between Welch Boltimate® Core-shell HPLC column and Waters Cortecs®  HPLC Column . This report presents and discusses the results obtained in the equivalency study.

Column

  1. Welch Boltimate ® Core-shell, LP-C18 (100 x 2.1)mm, 2.7µm
  2. Waters CORTECS®  C18 (100 x 2.1)mm, 2.7µm

Chromatographic system

PreColumnEnd-capped solid core octadecylsilyl silca gel (0.005m x 2.1mm, 2.7µm)
Column1. Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm
2. Waters Cortecs® C18 (100 x2.1)mm, 2.7µm
Wavelength254nm
Flow rate0.3mL/minute
Injection Volume5 µL
Column temperature30°C
Auto sampler temperature25°C

Results

1. Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

2. Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

ParameterColumn-1Column-2
The Resolution between the peak due to impurity K and paracetamol10.323.0

NameRelative Retention Time
(As per EP)
Relative Retention Time
(Column-1)
Relative Retention Time
(Column-2)
Impurity K0.40.400.38
Impurity J10.18.179.34

Conclusion

From the results of equivalency study, the equivalency between the Welch Boltimate® HPLC column and Waters Cortecs®  HPLC column is proved. Hence a Welch Boltimate® HPLC Column can be used for related substances by HPLC of Paracetamol API as per EP monograph.

Chromatograph of Solvent mixture

Fig 1: Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

Fig 2: Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

Chromatograph of Reference solution (a)

Fig 3: Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

Fig 4: Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

Chromatograph of Reference solution (b)

Fig 5: Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

Fig 6: Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

Chromatograph of Reference solution (c)

 Fig 7: Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

Fig 8: Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

Chromatograph of Test Solution

Fig 9 :Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm

Fig 10: Waters Cortecs® C18 (100 x2.1)mm, 2.7µm

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


1 Comment

Форекс брокерийн компани · August 26, 2021 at 6:36 am

Your means of describing everything in this post is in fact pleasant, every one
be capable of easily be aware of it, Thanks a lot.

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