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Validated HPLC method for quantifying permethrin in pharmaceutical formulations.

E García1, A García, C Barbas

  • 1Facultad de CC Experimentales y Técnicas, Universidad San Pablo-CEU, Urbanización Montepríncipe, Ctra. Boadilla del Monte, km 5,3-28668 Madrid, Spain.

Journal of Pharmaceutical and Biomedical Analysis
|March 15, 2001
PubMed
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A new HPLC method accurately determines permethrin in raw materials and pharmaceuticals like lotions and shampoos. This validated method ensures separation of isomers, impurities, and degradation products for quality control.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Permethrin is a widely used insecticide in pharmaceutical formulations.
  • Accurate quantification of permethrin is crucial for ensuring product efficacy and safety.
  • Existing analytical methods may lack the specificity or efficiency required for complex matrices.

Purpose of the Study:

  • To develop and validate a robust isocratic High-Performance Liquid Chromatography (HPLC) method for permethrin determination.
  • To ensure the method can accurately quantify permethrin in both raw materials and finished pharmaceutical products (lotion, shampoo).
  • To validate the method according to International Council for Harmonisation (ICH) guidelines.

Main Methods:

  • Isocratic HPLC using a C-18 Nova-Pak column (15 x 0.39 cm, 4 µm particle size) at 35°C.

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  • Mobile phase: methanol-water (78:22, v/v) at a flow rate of 1 mL/min.
  • UV detection at 272 nm, with peak identification by retention time and photodiode array (PDA) spectral confirmation.

    • Main Results:

    • The developed HPLC method demonstrated excellent separation of permethrin cis- and trans- isomers.
    • The method effectively resolved impurities and potential degradation products from the main permethrin peak.
    • Validation according to ICH guidelines confirmed the method's reliability for permethrin quantification.

    Conclusions:

    • A validated, isocratic HPLC method is suitable for the determination of permethrin in raw materials and pharmaceutical formulations.
    • The method provides reliable separation and quantification, supporting quality control in pharmaceutical manufacturing.
    • This analytical approach enhances the safety and efficacy assessment of permethrin-containing products.