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Water determination in drugs containing ascorbic acid.

F Sherman1, I Kuselman

  • 1National Physical Laboratory of Israel, Givat Ram, Jerusalem, Israel.

Drug Development and Industrial Pharmacy
|October 26, 1999
PubMed
Summary
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A new analytical method allows for simultaneous determination of water and ascorbic acid in vitamin C tablets. This rapid technique overcomes limitations of direct Karl Fischer titration for these complex samples.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Ascorbic acid in vitamin C tablets interferes with direct Karl Fischer titration for water content.
  • Accurate water determination is crucial for pharmaceutical product stability and quality.

Purpose of the Study:

  • To develop and validate a rapid analytical method for simultaneous water and ascorbic acid determination in vitamin C tablets.
  • To overcome the interference of ascorbic acid in Karl Fischer titration.

Main Methods:

  • A novel consecutive titration approach was employed.
  • The method involves initial titration of ascorbic acid with a new reagent (iodine, potassium iodide, sodium acetate in non-aqueous medium).
  • Subsequent titration of water is performed using a conventional Karl Fischer reagent (KFR) in the same sample cell, with electrometric endpoint detection.

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Main Results:

  • The new analytical method demonstrated satisfactory repeatability and accuracy for both water and ascorbic acid quantification.
  • The method is applicable to vitamin C tablets like Ce De Calcium Veterinary and C-Tamin-500.

Conclusions:

  • The developed method provides a reliable and efficient alternative for analyzing water content in ascorbic acid-containing pharmaceutical formulations.
  • This technique simplifies the analytical process by enabling consecutive determination in a single sample and cell.