engleski

Development and validation of an HPLC method for simultaneous determination of capsaicinoids and camphor in over-the-counter medication for topical use

A reverse-phase high-performance liquid chromatography method was developed to determine and quantify capsaicin (trans-8-methyl- N- vanillyl-6- nonenamid), dihydrocapsaicin (8- methyl-N-vanillylnonanamide), and camphor (trimethylbicyclo[2.2.1]heptan-2-one). It is applicable in analyses of over-the-counter (OTC) medications for topical use and raw materials such as chili pepper oleoresin. Chromatographic separation was carried out on a C18 column using an isocratic flow of the mobile phase containing acetonitrile and ultrapure water in a ratio of 2:3, with pH adjusted to 3.2 using glacial acetic acid, and a flow rate of 1.5 mL/min. The concentration of the eluting compounds was monitored by a diode-array detector at a wavelength of 281 nm. The method was evaluated for several validation parameters, including selectivity, accuracy (confidence intervals < 0.05%), repeatability, and intermediate precision. The limit of detection (LOD) was determined to be 0.070 g/mL for capsaicin, 0.211 g/mL for dihydrocapsaicin, and 0.060 g/mL for camphor. The limit of quantification (LOQ) was determined to be 0.212 g/mL for capsaicin, 0.640 g/mL for dihydrocapsaicin, and 0.320 g/mL for camphor. Linearity was set in the range of 2.5–200 g/mL for capsaicin and dihydrocapsaicin and 25–2000 g/mL for camphor. The suggested analytical method can be used for quality control of formulated pharmaceutical products containing capsaicinoids, camphor, and propolis.

capsaicin ; dihydrocapsaicin ; camphor ; HPLC ; validation ; OTC

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