title: Development of the HPLC Method for Simultaneous Determination of Lidocaine Hydrochloride and Tribenoside Along with Their Impurities Supported by the QSRR Approach.
abstract: A new liquid chromatographic (LC) method for simultaneous determination of lidocaine hydrochloride (LH) and tribenoside (TR) along with their related compounds in pharmaceutical preparations is described. Satisfactory LC separation of all analytes after the liquid-liquid extraction (LLE) procedure with ethanol was performed on a C18column using a gradient elution of a mixture of acetonitrile and 0.1 % orthophosphoric acid as the mobile phase. The procedure was validated according to the ICH guidelines. The limits of detection (LOD) and quantification (LOQ) were 4.36 and 13.21 μg mL-1for LH, 7.60 and 23.04 μg mL-1for TR, and below 0.11 and 0.33 μg mL-1for their impurities, respectively. Intra- and inter-day precision was below 1.97 %, whereas accuracy for all analytes ranged from 98.17 to 101.94 %. The proposed method was sensitive, robust, and specific allowing reliable simultaneous quantification of all mentioned compounds. Moreover, a comparative study of the RP-LC column classification based on the quantitative structure-retention relationships (QSRR) and column selectivity obtained in real pharmaceutical analysis was innovatively applied using factor analysis (FA). In the column performance test, the analysis of LH and TR in the presence of their impurities was carried out according to the developed method with the use of 12 RP-LC stationary phases previously tested under the QSRR conditions. The obtained results confirmed that the classes of the stationary phases selected in accordance with the QSRR models provided comparable separation for LH, TR, and their impurities. Hence, it was concluded that the proposed QSRR approach could be considered a supportive tool in the selection of the suitable column for the pharmaceutical analysis.
authors.affiliation: Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Hallera 107, 80-416 Gdańsk, Poland.
authors.forename: Alina
authors.initials: A
authors.lastname: Plenis
authors.forename: Lucyna
authors.initials: L
authors.lastname: Konieczna
authors.forename: Natalia
authors.initials: N
authors.lastname: Miękus
authors.forename: Tomasz
authors.initials: T
authors.lastname: Bączek
keywords: Column Liquid chromatography; Column classification; Factor analysis; Impurities; Lidocaine hydrochloride; Quantitative structure-retention relationships; Tribenoside