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 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.

Stability‐indicating HPLC method for acyclovir and lidocaine in topical formulations

“…Several stability-indicating HPLC methods for the independent analysis of acyclovir (Bahrami, Mirzaeei, & Kiani, 2005;Brown, White, Chu, & Bartlett, 2002;Dao, Jiao, & Zhong, 2008;Fernández, Sepúlveda, Aránguiz, & von Plessing, 2003;Hasan, Chander, Ali, Baboota, & Ali, 2011;Huidobro, Ruperez, & Barbas, 2005;Stagni, Ali, & Weng, 2004;Tzanavaras & Themelis, 2007) or lidocaine (Gebauer, McClure, & Vlahakis, 2001;Malenovic, Medenica, Ivanovic, Jancic, & Markovic, 2005;Pendela, Kahsay, Baekelandt, Van Schepdael, & Adams, 2011;Plenis, Konieczna, Miękus, & Bączek, 2013;Prathyusha, Shanmugasundaram, & Naidu, 2013) in various formulations have been reported in the literature. To the best of our knowledge, no HPLC method has been reported for the simultaneous determination of acyclovir and lidocaine in combination formulations so far.…”

HPTLC Method Development for Simultaneous Estimation of Lidocaine and Prilocaine in Topical Formulation.

“…In order to determine Prilocaine and Lidocaine, many studies have been reported in literature. Several spectrophotometric [4][5][6], chromatographic [7][8][9][10][11][12][13][14][15][16][17][18], LC-MS/MS [19][20][21] and GC-MS [22][23][24] and capillary electrophoresis [25] techniques were developed in order to determine Prilocaine and Lidocaine in both pharmaceutical preparations and human plasma. The aim of the present work is to develop and validate a new high performance liquid chromatography (HPLC) and high performance thin layer chromatography (HPTLC) methods for determination of Prilocaine and Lidocaine in topical formulation.…”

Development and Validation of HPLC Method for Simultaneous Determination of Lidocaine and Prilocaine in Topical Formulation

“…To determine PLC and LDC, many studies have been reported in literature. Several spectrophotometric [4][5][6], chromatographic [7][8][9][10][11][12][13][14][15][16][17][18], liquid chromatography-tandem mass spectrometry [19][20][21], and gas chromatography-mass spectrometry [22][23][24] and capillary electrophoresis [25] techniques were developed to determine PLC and LDC in both pharmaceutical preparations and human plasma. The aim of the present work is to develop and validate a new high-performance liquid chromatography (HPLC) method for determination of PLC and LDC in topical formulation.…”