PREPARATION AND STABILITY EVALUATION OF LL-37 CREAM
Keywords:LL-37, cream, high performance liquid chromatography, stability, diabetic foot ulcer
Objective: The present study aimed to prepare LL-37 in a cream formulation (O/W emulsion) and evaluate its stability by determining the physical changes in the cream and concentration of LL-37 using validated high-performance liquid chromatography.
Methods: The method was conducted at room temperature using a C18 column (5 µm × 250 mm × 4.6 mm) as a stationary phase, a mixture of 0.1% trifluoroacetic acid (TFA)/water (A) and 0.1% TFA/acetonitrile (B) (85 : 15) as the mobile phase, a flow rate of 1.0 mL/min, and photodiode array set at 228 nm as the detector. The method was validated in compliance with the Association of Official Analytical Chemists and International Conference on Harmonization guidelines. It demonstrated excellent linearity, accuracy, precision, specificity, limit of detection, and limit of quantitation.
Results: The chromatographic analysis indicated minimal degradation of LL-37 during the 12-week, with a predicted expiry time of 99 and 75 months stored at 4 °C and 28 °C, respectively.
Conclusion: LL-37 cream establishes good physical characteristics and stabilizes the active ingredient, especially at 4°C and 28°C storage. Therefore, the emulsion delivery system of LL-37 cream is harmless and stable as a novel alternative vehicle of LL-37.
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