Determination of Paracetamol in pure form and in dosage forms using N,N-dibromo dimethylhydantoin

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Abstract

Paracetamol (Acetaminophen) is one of the most frequently used analgesic drugs. At therapeutic dosage levels the drug is relatively non-toxic. Because of its increasing therapeutic use, its assay and quality control are of vital importance. A number of methods, including instrumental 1, 2, 3, 4and titrimetric 5, 6, 7, are available for the quantitative determination of paracetamol in literature. A simple and accurate titrimetric method has been developed for the assay of paracetamol in pure form and in dosage forms, using N,N-dibromo dimethylhydantoin (DBH). Though a number of N-halo compounds are available for the determination of pharmaceuticals 8, 9, 10, DBH has greater advantages over such reagents [11].

Section snippets

Reagents

N,N-dibromo dimethylhydantoin (DBH) was prepared by brominating dimethylhydantoin. A standard solution (≈0.01 M) was prepared in water as reported previously [11].

Pure paracetamol obtained as a gift sample from Kerala State Drugs and Pharmaceuticals, Alleppey, Kerala, India, was further purified by recrystallization from ethanol and then used.

Paracetamol tablets such as Calpol (Burrough Wellcome India, Bombay), Crocin (Duphar Interfran, Bombay), Fepanil (Citadal Fine Pharma. Madras), Ifimol

Procedure

To a measured volume (5–15 ml) of the sample solution, two drops of amaranth indicator were added. This was titrated with standard DBH solution. The end point was the disappearance of the pink colour. From the titre value the amount of paracetamol was calculated from the equationW=M×V×Nnmgwhere M is the relative molecular mass of paracetamol, V is the volume of DBH of normality N, consumed and n is the equivalence number (here it is 4).

Results and discussion

Typical results of the titrations of paracetamol (pure) are presented in Table 1. From an examination of Table 1, it is revealed that 1 M of paracetamol consumed 4 equivalents of DBH. Table 2 gives a detailed data on the analysis of paracetamol formulations with DBH. The presently developed method has been compared with the reported ferricyanide method [7](titrimetric) and also the official method [4](spectrophotometric) and the results are included in Table 2. To check the validity of the

Acknowledgements

The authors thank Dr G. Karthikeyan, Proffessor and Head of Chemistry, Gandhigram Rural Institute and Dr P. Indrasenan, Proffessor of Chemistry, Kerala University for their valuable suggestions. We are also grateful to the University Grants Commission, Govternment of India for financial assistance in the form of a research project.

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