A new reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of pediatric oral powder formulation containing cefixime (CFX) and clavulanic acid (CVA). In this research, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of methanol and water containing disodium hydrogen phosphate in ratio of 20 : 80 v/v as the mobile phase (pH 5.5 adjusted with orthophosphoric acid) at a flow rate of 1.0 mL/min. The detecting wavelength and run time were 220 nm and 15 min, respectively. Moreover, the column temperature was maintained at 30°C. The analytical method was validated prior to meeting the conditions specified by International Conference on Harmonization (ICH) and the parameters were specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, robustness, and solution stability. The calibration curve was found to be linear between the concentration ranges of 0.024–0.036 mg/mL and 0.032–0.048 mg/mL for CFX and CVA, respectively. Furthermore, the LOD and LOQ of CFX were 0.0008 and 0.0025 μg/mL, respectively. Accordingly, LOD and LOQ of CVA were 0.0021 and 0.0065 μg/mL, respectively. The accuracy of the optimized method was examined by recovery studies and the mean recovery was observed to be 98.96% and 99.05% for CFX and CVA, respectively, at 100% spiked level. The repeatability testing for both standard and sample solutions revealed that the method is precise within the acceptable range and the %RSD of the precision was <2%. In addition, the findings of specificity, linearity, accuracy, precision, robustness, LOD, LOQ, and solution stability studies of both CFX and CVA were within the criteria of acceptable limit as well.

Luliconazole (LCZ) is a new antifungal agent containing imidazole moiety which revealed broad-spectrum antifungal activity. The aim of this research was to prepare water-in-oil (w/o) emulsion-based cream formulation of LCZ in addition to the development and validation of an analytical method by reverse-phase high-performance liquid chromatography (RP-HPLC). Cetostearyl alcohol (12.14%), light liquid paraffin (5.00%), white soft paraffin (2.75%), and Tween-80 (1.00%) appeared as the optimized concentration to give better consistency to the cream. Moreover, without adding pH adjusting agents the pH of the optimized formulation (F5) was obtained within the range of human skin pH throughout the stability period. The value of particle size, polydispersity index, and zeta potential was 187.90 ± 2.061 nm, 0.124 ± 0.026, and -10.553 ± 1.349 mV, respectively. In this study, an analytical C18 (4.6 mm × 25 cm), 5 μm column was used for chromatographic separation with a mixture of acetonitrile and water in the proportion of 50 : 50 v/v as the mobile phase at a flow rate of 1.0 mL/min. The calibration curve was obtained linear at 296 nm in the concentration range of 0.08–0.12 mg/mL. Furthermore, the limit of detection (LOD) and limit of quantification (LOQ) were 0.0013 and 0.0042 µg/mL, respectively. In addition, the observed results demonstrated that our developed method was linear (R2 = 0.999), precise (%RSD below than 2.0%), and accurate (mean recovery% = 100.18–100.91). The F5 showed no physical changes until 6th month analysis at room temperature and accelerated conditions. Similarly, the assay obtained 101.99% ± 0.27 and 99.89% ± 0.08 at room temperature and accelerated conditions, respectively. Additionally, all validated parameters were obtained within the acceptable limit as well. These findings conclude that both physically and chemically stable w/o cream formulation of LCZ can be formulated and assessed for their stability by applying the authenticated analytical procedure of RP-HPLC.