| خلاصه مقاله | Introduction: Kojic acid and azelaic acid are skin-lightening agents used in the treatment of melisma. Both of them can decrease the production of melanin through the inhibition of tyrosinase. These ingredients are utilized in the extemporaneous preparation. However, the compatibility between them is not studied yet. Therefore, in recent study, the physicochemical compatibility of kojic acid with azelaic acid is evaluated.
Methods and Materials: kojic acid and azelaic acid were mixed (in the ratio of 1:1) using vortex mixer. Then, 20% w/v water was added and mixed well. These samples were kept in the oven at 40 °C for two months. DSC and FT-IR were employed to analyze the compatibility. A validated HPLC-UV analytical method was performed to quantify the amount of kojic acid remaining after stress.
Results: The color of the mixtures containing kojic acid and azelaic acid was changed visually. DSC and FT-IR data illustrated the initial incompatibility of the formulations. The absence of endothermic peak (114 °C) in the DSC thermogram of azelaic acid and the lack of stretching vibration peak at 1696 cm-1 refer to the degradation of azelaic acid. Also, the HPLC outcome, indicated 81.82 ± 3.68 % of kojic acid remaining in the samples after stress test. This finding is in confirmation with the incompatibility of kojic acid with azelaic acid. This method have a good linearity (10-80 µg/mL), acceptable accuracy (98-99.5%), precision (RSD<2%), low LOD, and LOQ (2.65, 8.04 µg/mL, respectively).
Conclusion: The results of DSC, FT-IR, and HPLC proved incompatibility between kojic acid and azelaic acid. It can be recommended to avoid using these ingredients in combination in a unit pharmaceutical dosage form. |