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European Pharmacopoeia Paracetamol Monograph Draft Method: Achieving Improved Sensitivity, Resolution, and Separation for Paracetamol and All 14 Related Impurities using Kinetex® 5 µm C18 Core-Shell Columns
For this report, we focused on the complex related substances profile of paracetamol as identified in the Pharmeuropa draft monograph (PA/PH/Exp. 10A/T (19) 136 ANP – 32.1). This draft is currently under review to possibly replace the existing monograph. By leveraging column selectivity, we were able to provide improved resolution for paracetamol and the principal degradation product, 4-aminophenol (impurity K), an impurity that can be formed by the hydrolysis of paracetamol. The Pharmeuropa draft monograph requires that resolution between impurity K and paracetamol be a minimum of 5.0 to meet system suitability; resolution significantly greater than this was achieved here. In addition, resolution of all 14 related impurities was achieved. The proposed draft method for paracetamol utilizes a superficially porous 5 μm column (HALO® 5 μm C18 150 x 4.6 mm) in the same dimension as the Kinetex C18 5 μm core-shell column used here. The performance of the Kinetex 5 μm core-shell column was compared with the performance of the superficially porous HALO C18 column and all method parameters (column dimension, injection volume, and gradient mobile phase conditions) were consistent with the Pharmeuropa draft monograph for paracetamol.
European Pharmacopoeia Paracetamol Monograph Draft Method: Achieving Improved Sensitivity, Resolution, and Separation for Paracetamol and All 14 Related Impurities using Kinetex® 5 µm C18 Core-Shell Columns
For this report, we focused on the complex related substances profile of paracetamol as identified in the Pharmeuropa draft monograph (PA/PH/Exp. 10A/T (19) 136 ANP – 32.1). This draft is currently under review to possibly replace the existing monograph. By leveraging column selectivity, we were able to provide improved resolution for paracetamol and the principal degradation product, 4-aminophenol (impurity K), an impurity that can be formed by the hydrolysis of paracetamol. The Pharmeuropa draft monograph requires that resolution between impurity K and paracetamol be a minimum of 5.0 to meet system suitability; resolution significantly greater than this was achieved here. In addition, resolution of all 14 related impurities was achieved. The proposed draft method for paracetamol utilizes a superficially porous 5 μm column (HALO® 5 μm C18 150 x 4.6 mm) in the same dimension as the Kinetex C18 5 μm core-shell column used here. The performance of the Kinetex 5 μm core-shell column was compared with the performance of the superficially porous HALO C18 column and all method parameters (column dimension, injection volume, and gradient mobile phase conditions) were consistent with the Pharmeuropa draft monograph for paracetamol.
Document Type:
Technical Notes
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Reversed Phase
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