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Validated HPTLC Method for Simultaneous Quantitation of Paracetamol, Diclofenac Potassium, and Famotidine in Tablet Formulation

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A sensitive, simple, selective, precise, and accurate HPTLC method of analysis for paracetamol, diclofenac potassium, and famotidine both as a bulk drug and in tablet formulation was developed and validated. The method used HPTLC aluminum plates precoated with silica gel 60F254 as the stationary phase, and the mobile phase consisted of tolueneacetonemethanolformic acid (5 + 2 + 2 + 0.01, v/v/v/v). Densitometric evaluation of the separated zones was performed at 274 nm. This system was found to give compact spots for paracetamol (Rf value = 0.62 0.03), diclofenac potassium (0.75 0.02), and famotidine (0.17 0.03). The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 16259750 ng/spot for paracetamol, 2501500 ng/spot for diclofenac potassium, and 100600 ng/spot for famotidine. The method was validated for precision, robustness, and recovery according to International Conference on Harmonization guidelines. No chromatographic interference from the tablet excipients was found. Statistical analysis showed that the method was repeatable and selective for the simultaneous quantitation of the three drugs in tablet formulation and for routine quality control of raw materials of the drugs.
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Document Type: Research Article

Affiliations: Bharati Vidyapeeth University, Poona College of Pharmacy, Department of Pharmaceutical Chemistry, Pune, Maharashtra, India 411038.

Publication date: May 1, 2010

More about this publication?
  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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