QUANTITATIVE DETERMINATION OF THE INNOVATIVE NEOPIOID ANALGETIC IN A MUKOADAGESIVE DOSAGE FORM
Introduction. The TRPA1 channel blocker (ZC02-0012) is an innovative drug belonging to the class of non-opioid analgesics. According to the results of his pharmacokinetic studies, a decision was made on the expediency of developing its prolonged dosage form, which was chosen as biopolymer films, which are one of the innovative long-acting dosage forms intended for topical application and possessing a number of positive properties. In order to standardize the dosage form in terms of the "Quantitative Content" indicator, there was developed a method using a highly efficient liquid chromatograph with a diode-array detector. Materials and methods. The subject of the study includes biopolymer films containing a non-opioid analgesic, a blocker of TRPA1 channels (ZC02-0012). The quantitative content of the non-opioid analgesic was confirmed by HPLC under the following conditions: instrument – a liquid chromatograph with a working pressure range of 0-60 mPa; detector is spectrophotometric with a diode array system operating in the range of 195-400 nm; protective column – Zorbax SB C8 12.5 × 4.6 mm with a particle size of 5.0 μm; column – Zorbax SB C8 150 × 4.6 mm with a particle size of 3.5 μm; mobile phase A – 10.35 g/l KCLO4 + 2.6 ml/l HCLO4; mobile phase B – acetonitrile; the temperature of the sample thermostat is 5ºC; the temperature of the column thermostat is 40ºC; injection volume – 20 μl; retention time of ZC02-0012 is about 7.0 minutes; wavelength is 291 nm (190-400 nm for identification); separation mode – linear gradient elution. The method of quantitative determination of a non-opioid analgesic in a biopolymer film was studied by validation characteristics: specificity, accuracy, linearity and precision. Results and discussion. Validation procedure proved the accuracy, linearity and precision of the method of quantitative determination of a non-opioid analgesic in a biodegradable polymeric film in the concentration range of 80-120% of the nominal content of a pharmacologically active substance. The validation characteristics of the method were obtained: accuracy (ermax – 0.31%, er average – 0.07%, Δer = 0.04%); linearity (linear dependence of optical density on analgesic concentration is observed, r = 0.99987); precision (Sraverage – 1.45%, εaverage – 1.03%). The quantitative content of the non-opioid analgesic in the biopolymer film ranges from 90% to 110%. Conclusion. The developed and validated method for the quantitative determination of the non-opioid analgesic was successfully applied to standardize the biopolymer film ZC02-0012 in terms of the "Quantitative content" indicator.