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 C18 column 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−1 for LH, 7.60 and 23.04 μg mL−1 for TR, and below 0.11 and 0.33 μg mL−1 for 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.
Highlights
Tribenoside (TR), chemically a mixture of the a- and b-anomers of ethyl 3,5,6-tri-O-benzyl-D-glucofuranoside (TRa, TRb), demonstrates anti-inflammatory, mild analgesic, antitoxic, wound-healing, fibrinolysis-promoting, anti-arthrotic, amine-release-inhibitory, membrane-stabilising, and venotropic properties
A comparative study of the RP-liquid chromatographic (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)
A simple, precise, and accurate LC-UV method was developed for simultaneous determination of lidocaine hydrochloride (LH), TR, and their impurities in pharmaceutical preparations allowing to reduce imprecision related to sample handling, shortening the time of the analysis, and reducing its costs
Summary
Tribenoside (TR), chemically a mixture of the a- and b-anomers of ethyl 3,5,6-tri-O-benzyl-D-glucofuranoside (TRa, TRb), demonstrates anti-inflammatory, mild analgesic, antitoxic, wound-healing, fibrinolysis-promoting, anti-arthrotic, amine-release-inhibitory, membrane-stabilising, and venotropic properties. The mechanism of pharmacological activity of lidocaine hydrochloride (LH), chemically 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide hydrochloride, is different This drug belongs to the widest used local anaesthetic agents applied in regional management of major pain, administered spinally and epidurally or peripherally. Eur.) [1] and British Pharmacopeia (BP) [2] Both monographs describe the LC procedures for the determination of LH and its two impurities: 2,6dimethylaniline (DMA) and 2-chloro-20,60-acetoxylidide (CAX), as well as TR along with its related compounds: benzaldehyde (BA), dibenzyl ether (DBE), plus tribenoside impurity A (TRA). These methods are based on different chromatographic conditions making simultaneous determination of LH and TR in a single LC run time impossible. To the best of our knowledge no method has so far been reported for simultaneous quantitative determination of LH and TR along with their impurities in pharmaceutical products
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