Фармация и фармакология (Пятигорск) (Aug 2017)
DETERMINATION OF RELATED IMPURITIES IN THE ANILOCAINE SUBSTANCE BY HPLC METHOD
Abstract
Anilocaine is a local anesthetic from the group of substituted amides, synthesized in the Perm State Pharmaceutical Academy. Anilocaine shows high surface anesthetic, infiltration and conduction anesthesia and shows the high efficiency in the various fields of medical practice. The quality of produced medicines depends on the quality of pharmaceutical substances. The purity is one of the most important parameters of the quality of pharmaceutical substances. The aim of this work was the development and validation of methods for identification of specific impurities in the substance of anilocaine by high-performance liquid chromatography (HPLC). Materials and methods. Studies were performed on liquid chromatography LC-20 Prominence (Shimadzu, Japan) equipped with a diode-array detector (SPD-M20A). Chromatographic column was Zorbax SB-C18 (4.6 mm × 250 mm, 5 μm). Validation assessment of the developed method conducted in accordance with the requirements of FP XIII and international requirementsICH (International Conference on Harmonization). Results and discussion. An experiment on the selection of the conditions of chromatographically showed that optimal separation of anilocaine and possible impurities (identified and unidentified) by the method of reversed-phase HPLC is observed in isocratic mode, using an eluent based on phosphate buffer pH 3 and acetonitrile. The flow rate of mobile phase is 1 ml/min; wavelength detection is 210 nm. Time check chromatogram is 20 minutes. Conclusion. The method for the quantitative determination of impurities in the substance of anilocaine by high-performance liquid chromatography was developed as the result of the research. The validation procedure of the analytical methods established its specificity, linearity, precision and accuracy. This method is included in the project monograph on substance of anilocaine.
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