Development of the simultaneous analysis of choline salicylate, lidocaine hydrochloride and preservatives in a new dental gel by HPLC method

Abstract

Sukurtas naujas aukšto efektyvumo skystinės chromatografijos analizės metodas, skirtas vienalaikiam cholino salicilatui, lidokaino hidrochloridui ir konservantams naujame dantų gelyje nustatyti. Metodas optimizuotas parenkant mobiliosios fazės sudėtį ir detekcijos bangos ilgį. Naudojamas gradientinis atskyrimas acetonitrilu ir fosfatinio buferio tirpalu pH 3,0. Detekcija vykdoma esant 260 nm bandos ilgiui. A new high-performance liquid chromatography (HPLC) method for the simultaneous quantitative determination of active pharmaceutical substances and preservatives in a new dental medication has been developed. The optimization of HPLC method parameters was done through studies of a mobile phase composition and a detection wavelength. Our developing method uses an ACE C18 column (250 × 4.6 mm, 5 µm) and a gradient mode for separation with the acetonitrile and phosphate buffer solution (adjusted to pH 3.0) as mobile phases. The flow rate is 1 ml/ min, and the detection was set at 260 nm (DAD). The method was evaluated according to the ICH guidelines and the State Pharmacopoeia of Ukraine in terms of specificity, accuracy, linearity and precision (repeatability and intermediate precision). The limit of detection and the limit of quantification were also calculated. The developed method was put in place for the analysis of a combined dental gel to a quantitative determination of the APIs (choline salicylate, lidocaine hydrochloride) and preservatives (methylparaben, propylparaben).