Research for detecting and quantitation of prohibited substance theophylline in some cosmetic matrices by liquid chromatography

Thu Trang Do1, , Van Ha Nguyen1
1 National Institute of Drug Quality Control

Main Article Content

Abstract

A reverse-phase liquid chromatography method was developed to detect and assay theophylline in the cream and the lotion. Chromatographic conditions are as follows: The liquid chromatograph is equipped with a 270 nm detector, a 250 x 4.6 mm column that contains 5 µm packing octadecyl silane, a mixture of methanol and water (25:75) as mobile phase, the flow rate of about 1.0 ml/min, injection volume is 20 µl, temperature: ambient.
The method was validated about the specificity, linear range, precision, accuracy, range, detection limit, and quantitation limit and validation results proved that this method was suitable for the determination of theophylline in the cream and lotion.

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References

1. Hội đồng Dược điển Việt Nam (2017), Viên nén Theophyllin, Dược điển Việt Nam V, Nhà xuất bản Y học, Hà Nội.
2. Hội đồng Dược thư quốc gia Việt Nam (2018), Dược thư quốc gia Việt Nam, Nhà xuất bản Y học, Hà Nội.
3. Association of South East Asian nations- ASEAN (2022), Annex II- List of substances which must not form part of the composition of cosmetic products.
4. Bertolini M., et. al. (2020), Theophylline exerts complex anti-ageing and anti-cytotoxicity effects in human skin ex vivo, Int J Cosmet Sci; 42(1), pp. 79-88.
5. International Conference on Harmonization (2005), Validation of Analytical Proceduce: Text and Methodology Q2(R1).
6. The United States Pharmacopeial Comvention (2021), The United States Pharmacopoeia 43 and the national Formulary 38, The USA.