SELECTIVE TRACE LEVEL DETERMINATION OF 1,4-DIOXANE CONTENT IN SODIUM LAURETH SULFATE RAW MATERIAL BY GAS CHROMATOGRAPHIC-FLAME IONIZATION DETECTION METHOD

  • LAKSHMI NARASIMHA RAO KATAKAM Department of Analytical Development, Saptalis Pharmaceuticals LLC, Hauppauge, New York 11788, USA.
  • THIRUPATHI DONGALA Department of Analytical Research and Development, Aurex Laboratories LLC, New Jersey 08520, USA.

Abstract

Objective: The study spotlights on a new gas chromatographic (GC) method with flame ionization detection technique that has been developed and validated for the selective determination of 1,4-dioxane content in sodium laureth sulfate (SLS), raw material.


Methods: The method was developed using a Thermo Scientific TR-1 (30 m×0.25 mm×1.0 μm) column with a carrier gas used as helium. The diluent used as purified water and the flow pressure of the carrier gas is 9.0 psi with a split ratio of 1:5. The optimized method was validated as per the ICH Q2 guidelines.


Results: Regression analysis confers a correlation coefficient for the stated compounds that are found to be greater than 0.999. The limit of quantitation and limit of detection are established at a sensitive determination level of 9 ppm and 3 ppm, respectively.


Conclusion: The validated and rugged GC method developed for the determination of 1,4-dioxane using a specific GC method in the SLS raw material. The recovery results prove the sound judgment in the determination of accuracy toward its evaluation. Hence, the validated analytical method was specific, selective, economical, and accurate for the determination of 1,4-dioxane by gas chromatographic method with flame ionization detection technique.

Keywords: 1,4-Dioxane, Sodium laureth sulfate, Raw material, Gas chromatographic with flame ionization detection, Trace level determination

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RAO KATAKAM, L. N., and T. DONGALA. “SELECTIVE TRACE LEVEL DETERMINATION OF 1,4-DIOXANE CONTENT IN SODIUM LAURETH SULFATE RAW MATERIAL BY GAS CHROMATOGRAPHIC-FLAME IONIZATION DETECTION METHOD”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 13, no. 6, Apr. 2020, pp. 116-20, doi:10.22159/ajpcr.2020.v13i6.37435.
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