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Development and Validation of a New HPLC Method for the Simultaneous Determination of Paracetamol, Ascorbic Acid, and Pseudoephedrine HCl in their Co-formulated Tablets. Application to in vitro Dissolution Testing

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Abstract

The first HPLC method was developed for the simultaneous determination of paracetamol (PC), ascorbic acid (AA), and pseudoephedrine HCl (PE) in their co-formulated tablets. Separation was achieved on a C18 column in 5 min using a mobile phase composed of methanol-0.05 M phosphate buffer (35:65, v/v) at pH 2.5 with UV detection at 220 nm. Linear calibration curves were constructed over concentration ranges of 1.0–50.0, 3.0–60.0 and 3.0–80.0 μg mL–1 for PC, AA, and PE, respectively. The method was validated and applied for the simultaneous determination of these drugs in their tablets with average % recoveries of 101.17 ± 0.67, 98.34 ± 0.77, and 98.95 ± 1.11%, for PC, AA, and PE, respectively. The proposed method was also used to construct in vitro dissolution profiles of the co-formulated tablets containing the three drugs.

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Authors and Affiliations

  1. Department of Analytical Chemistry Faculty of Pharmacy, University of Mansoura, 35516 Mansoura, Egypt

    Fawzia Ibrahim, Nahed El-Enany, Rania N. El-Shaheny & Ibraam E. Mikhail

Authors
  1. Fawzia Ibrahim
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  2. Nahed El-Enany
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  3. Rania N. El-Shaheny
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  4. Ibraam E. Mikhail
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Corresponding author

Correspondence to Rania N. El-Shaheny.

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Ibrahim, F., El-Enany, N., El-Shaheny, R.N. et al. Development and Validation of a New HPLC Method for the Simultaneous Determination of Paracetamol, Ascorbic Acid, and Pseudoephedrine HCl in their Co-formulated Tablets. Application to in vitro Dissolution Testing. ANAL. SCI. 31, 943–947 (2015). https://doi.org/10.2116/analsci.31.943

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  • DOI: https://doi.org/10.2116/analsci.31.943

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