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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
Welch Boltimate ® Core-shell, LP-C18 (100 x 2.1)mm, 2.7µm
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
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
View PDF: https://www.welch-us.com/wp-content/uploads/2021/08/Paracetamol_Method-Equivalency-report-11.pdf
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