Ultrafast Liquid Chromatographic Estimation of Sertaconazole Nitrate in Pharmaceuticals Using Analytical Quality by Design

An analytical Quality by Design(AQbD) oriented ultra-fast liquid chromatography method was developed for quantification of sertaconazole nitrate in pharmaceutical dosage form. A central composite design (CCD) was employed to establish optimum chromatographic conditions ensuring method robustness by selecting methanol (%) and flow rate (mL/min) as the factors, to study their effect on the system suitability parameters such as retention time, plate number and tailing factor as the response variable. Further, the method was carried out with design of experiments (DoE) optimized chromatographic conditions. The intermediate precision of the method was studied using a full factorial design (FFD) considering the number of days and analysts as the variables. The chromatographic separation was achieved on a phenyl-hexyl column using methanol: water (92:8, %v/v) as the mobile phase at a flow rate of 1.3 mL/min and photo diode array detection at 260 nm. The values obtained for validation parameters were within the acceptance limit. The method was linear over 5-100 g/mL of sertaconazole. Analysis of the system suitability suggested a high degree of method reproducibility and robustness. In a nutshell, the method was found to be highly suitable for its applicability in the determination of sertaconazole in bulk and tablet dosage form.