DEVELOPMENT AND VALIDATION OF GC-FID METHOD FOR THE QUANTIFICATION OF 1, 4-DIOXANE IN HERBAL SHAMPOO Authors: Patel PH , CHUDASAMA PN, CKARABORTHY GS, SONI H AND PATEL V
ABSTRACT
1, 4-dioxane is a man-made chemical used primarily as an industrial solvent and also found
as organic volatile impurity in cosmetic products. A rapid, simple, accurate and precise
method has been developed for the estimation of 1, 4 dioxane in herbal shampoo by gas
hromatography coupled with flame ionization detector. Good resolution and sharpness of
peak were achieved by using Rtx 5 capillary column (30m x 0.25mm) with stationary phase
cross bond 5% diphenyl 95% dimethyl polysiloxane. 1, 4-dioxane was extracted out by
simple and rapid liquid-liquid extraction method using methanol and dichloromethane. The
amount of 1, 4-dioxane was found 9.32 ppm at retention time 3.52 mins in herbal shampoo.
The method validation was carried out with regard to the guidelines for analytical procedures
demanded by the International Conference on Harmonization (ICH Q2R1). The lower limit
of detection (LOD) and lower quantification limit (LOQ) were obtained 0.10ppm and
0.30ppm respectively. The linearity was over the range of0.5 ppm to 20 ppm with regression
coefficients higher than 0.997. The interday and intraday precision of the method was
achieved within 2% relative standard deviation (RSD) with % recoveries between 98 to102
percent. The robustness of the method done by changing levels of parameters and results
were achieved within 2% relative standard deviation (RSD). In specificity study, there was no
peak observed at the retention time of the 1, 4-dioxane in placebo.
Keywords: 1, 4-dioxane, Gas chromatography, Herbal shampoo
Publication date: 01/04/2022 https://ijbpas.com/pdf/2022/April/MS_IJBPAS_2022_6040.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.4.6040