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Pharmaceutical Chemistry Journal

, Volume 47, Issue 9, pp 503–508 | Cite as

Optimizing Quality Control of Docetaxel Drug Substance and its Parenteral Dosage Forms

  • M. S. Goizman
  • D. A. Arantseva
  • I. I. Demidova
  • M. B. Zagudailova
  • E. K. Kulaeva
  • M. G. Chernobrovkin
  • E. V. Degterev
Structure of Chemical Compounds, Methods of Analysis and Process Control

An HPLC method for quantitative determination of docetaxel and impurities in docetaxel drug substance and related dosage forms was developed for their quality control. Validation of the proposed method during the course of drug analysis stipulated separate statistical analysis of two groups of intermediate values with checking for the homogeneity of each group. Values in the first group were calculated as the ratio of areas under peaks of docetaxel in the chromatograms of test solutions to the chromatographed amounts of analyte. Values in the second group were calculated as the ratio of chromatographed amounts of docetaxel standard to the areas under peaks of docetaxel on the corresponding chromatograms. The docetaxel content was calculated as the product of the averaged intermediate values of the first and second groups. This increased the reliability of the results and decreased the amount of labor and consumption of standards. The confidence interval of docetaxel quantitative determination by the proposed method with reliability degree α = 0.05 was less than 1.5% for three analyses each of two test and two standard solutions. The average peak area of each impurity was determined on chromatograms of test solutions. The ratios of these values to the average docetaxel peak area in chromatograms of reference solutions prepared by diluting test solutions (1:1000) were found and were proportional to the contents of the corresponding impurities in the analyte to that of docetaxel (proportionality coefficient 0.1%). The confidence interval of the determination of an individual impurity for α = 0.05 was less than 6.5%.

Keywords

docetaxel authenticity quantitative determination taxane HPLC drug substance dosage form validation 

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Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • M. S. Goizman
    • 1
  • D. A. Arantseva
    • 1
  • I. I. Demidova
    • 1
  • M. B. Zagudailova
    • 1
  • E. K. Kulaeva
    • 1
  • M. G. Chernobrovkin
    • 1
  • E. V. Degterev
    • 2
  1. 1.Drug Technology Co.Moscow RegionRussia
  2. 2.Folium PublishingMoscowRussia

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