Determination of Diclofenac Sodium in Microemulsions, Microemulsion-based Gels, and Samples of Pig-Ear Skin Permeation Study by HPLC Method
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Abstract
This study was aimed to validate high performance liquid chromatography (HPLC) method for determination of diclofenac sodium (DS) formulated in forms of microemulsions (MEs) as well as microemulsion-based gels (MBGs) and in samples of pig-ear skin permeation study. The HPLC technique was performed by a reverse-phase C18 column (5 μm particle size, 4.6×150 mm), mobile phase containing a mixture of acetonitrile and 0.5% acetic acid solution in the ratio of 60:40 v/v at flow rate of 1.0 mL/min. The detection wavelength was set at 276 nm. The method was validated according to the ICH Q2(R1) guideline. It was found that the retention time of DS was about 6.1 minutes. This method could analyze the prepared MEs and MBGs without interference of inactive ingredients. Additionally, no interfering peaks of components in receptor fluid and extraction of skin membrane were observed near DS peak. Hence, the specificity was established. The calibration plots showed a good linear relationship over the concentrations of DS standard solutions in the range of 2.5 to 80 μg/mL. The method showed accuracy with high recoveries (99.00% to 101.99%). The percent relative standard deviations (%RSD) were 0.0296 to 0.0920 for intra-day and 0.0536 to 1.3413 for inter-day precisions. The limit of detection (LOD) and limit of quantitation (LOQ) were low as 0.06 μg/mL and 0.18 μg/mL, respectively. The findings confirmed that the studied HPLC method was suitable for quantitative assay of DS in novel nano-formulations and in samples of pig-ear skin permeation study with the simple and time-saving process.
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