Comparison between Welch Boltimate® HPLC & a well-known Core-shell HPLC Column by Paracetamol API as per EP.

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

PreColumn	End-capped solid core octadecylsilyl silca gel (0.005m x 2.1mm, 2.7µm)
Column	1. Welch Boltimate® LP C18 (100 x 2.1)mm, 2.7µm 2. Waters Cortecs® C18 (100 x2.1)mm, 2.7µm
Wavelength	254nm
Flow rate	0.3mL/minute
Injection Volume	5 µL
Column temperature	30°C
Auto sampler temperature	25°C

Results

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

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

Parameter	Column-1	Column-2
The Resolution between the peak due to impurity K and paracetamol	10.3	23.0

Name	Relative Retention Time (As per EP)	Relative Retention Time (Column-1)	Relative Retention Time (Column-2)
Impurity K	0.4	0.40	0.38
Impurity J	10.1	8.17	9.34

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

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

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

Chromatograph of Reference solution (a)

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

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

Chromatograph of Reference solution (b)

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

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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