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Paracetamol Soluble Tablets

The document provides chromatograms and methods for analyzing Paracetamol Soluble Tablets as per BP 2025 guidelines. It includes details on the related substances test and assay test, specifying columns, mobile phases, flow rates, and detection wavelengths. The information serves as guidance for analysts in interpreting the BP monographs.

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36 views3 pages

Paracetamol Soluble Tablets

The document provides chromatograms and methods for analyzing Paracetamol Soluble Tablets as per BP 2025 guidelines. It includes details on the related substances test and assay test, specifying columns, mobile phases, flow rates, and detection wavelengths. The information serves as guidance for analysts in interpreting the BP monographs.

Uploaded by

abdalparee
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Paracetamol Soluble Tablets – BP 2025

These chromatograms are provided for information only as an aid to analysts and are intended
as guidance for the interpretation and application of BP monographs.

Typical chromatogram for solution (5) from the Related Substances test for Paracetamol
Soluble Tablets as published in BP 2025.

Peak ID: 1: Impurity K. 2: Paracetamol.

Column Halo C18 (150 mm x 4.6 mm, 5 μm)

Method Ref. Related Substances for the Paracetamol Soluble Tablets


monograph from BP 2025

Mobile Phase A 1.7 g/L potassium dihydrogen phosphate and 1.8 g/L dipotassium
hydrogen phosphate

Mobile Phase B Methanol

Diluent 15% Methanol

Flow rate Refer to gradient table below

Column Temp 30°C

Injection Volume 50 µL

Page 1 of 3
Detection 254 nm

Gradient

Mobile phase A Mobile phase B Flow rate


Time (minutes) Comment
(% v/v) (% v/v) (mL/min)

0 – 1.5 95 5 1.5 isocratic

1.5 – 14.4 95 → 90 5 → 10 1.5 linear gradient

14.4 – 28.8 90 10 1.5 isocratic

28.8 – 57.6 90 → 66 10 → 34 1.5 linear gradient

57.6 – 60 66 34 1.5 isocratic

60 – 65 66 → 95 34 → 5 1.5 linear gradient

65 – 70 95 5 1.5 re-equilibration

Page 2 of 3
Typical chromatogram for solution (3) from the Assay test for Paracetamol Soluble Tablets as
published in BP 2025.

Peak ID: 1: Impurity K. 2: Paracetamol.

Column Agilent Zorbax Rx C8 (250 mm x 4.6 mm, 5 μm)

Method Ref. Assay for the Paracetamol Soluble Tablets monograph from BP
2025

Mobile Phase 250 volumes of methanol containing 1.15 g of a 40% w/v solution
of tetrabutylammonium hydroxide, 375 volumes of 0.05M disodium
hydrogen orthophosphate and 375 volumes of 0.05M sodium
dihydrogen orthophosphate

Diluent Mobile phase

Flow rate 1.5 mL

Column Temp 35°C

Injection Volume 20 µL

Detection 245 nm

Page 3 of 3

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