Abstract
A simple capillary zone electrophoresis (CZE) method was developed and validated for the analysis of lodenafil carbonate in tablets. Response surface methodology was used for optimization of the pH and concentration of the buffer, applied voltage and temperature. The method employed 50 mmol L-1 borate buffer at pH 10 as background electrolyte with an applied voltage of 15 kV. The separation was carried out in a fused-silica capillary maintained at 32.5 oC and the detection wavelength was 214 nm. The method was validated showing specificity, linearity (r = 0.9995), precision (relative standard deviation less than 2%) and accuracy (99.95%). The method proved to be robust by a fractional factorial design evaluation. The proposed CZE method was successfully applied for the quantitative analysis of lodenafil carbonate in tablets and the results compared to the high performance liquid chromatography and ultraviolet spectrophotometric methods, showed non-significant differences.
Highlights
Capillary electrophoresis (CE) has become one of the most advanced separation techniques for pharmaceutical analysis, quality control analysis of pharmaceuticals currently is performed predominantly with high-performance liquid chromatography (HPLC).[1,2] It has been proven that CE is a useful and reliable alternative and a complementary technique to HPLC in many areas, including the determination of the active pharmaceutical ingredients, drug related impurities, enantiomeric separations, identity confirmation andThe optimization of separation with CE is complex and difficult, because a high number of parameters, such as temperature, pH, voltage and buffer composition affect the separation
Central composite designs are by far the most widely used methods for the optimization of capillary zone electrophoresis (CZE) separations since they offer the possibility of evaluating the curvature of the data and fitting the experimental points to response surfaces.[25]
The optimization procedure was comprised of two steps: initial experiments and experimental design
Summary
Capillary electrophoresis (CE) has become one of the most advanced separation techniques for pharmaceutical analysis, quality control analysis of pharmaceuticals currently is performed predominantly with high-performance liquid chromatography (HPLC).[1,2] It has been proven that CE is a useful and reliable alternative and a complementary technique to HPLC in many areas, including the determination of the active pharmaceutical ingredients, drug related impurities, enantiomeric separations, identity confirmation andThe optimization of separation with CE is complex and difficult, because a high number of parameters, such as temperature, pH, voltage and buffer composition affect the separation. Rather than following the conventional monovariate approach used to adjust the parameters, involving a large number of independent analyses, one could advantageously replace the procedure by statistically designed experimental protocols, in which several factors are simultaneously varied. The optimized background electrolyte (BGE) solution used in this analysis was 50 mmol L-1 boric acid at pH 10. To prepare this solution 0.154 g of boric acid was diluted with 40 mL of water. Standard stock solution of LOC was prepared by accurately weighing 10 mg of LOC transferred to a 100 mL volumetric flask with 0.1 mol L-1 sodium hydroxide (100 μg mL-1). All solutions were stored at 2-8 oC, protected from light and diluted daily to an appropriate concentration with background electrolyte solution
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