PHYSICAL AND CHEMICAL STABILITY TEST OF NEEM OIL CREAM (Azadirachta indica) USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD
Objective: This study aims to examine the physical and chemical stability of neem oil cream.
Methods: Physical stability was conducted by storing the cream at room temperature (25 ± 2 °C / 65 %RH ± 5 %RH) and high temperature (40 ± 2 °C / 75 %RH ± 5 %RH) for 3 months. Method validation using Dionex HPLC with UV detector, Shodex (C-18) HPLC packed column (4.6 mmID x 250 mmL), acetonitrile:water [30:70] as mobile phase, 10 minutes isocratic elution with a flow rate of 1.0 mL/min with volume injection 20 μL, and UV detection at 219 nm was carried out to measure azadirachtin levels in neem oil cream. Chemical stability of azadirachtin was carried out by the validated method and carried out for 90 days.
Results: The neem oil cream was physically stable. The HPLC method of azadirachtin meets all the validation parameters and can be used to analyze the chemical stability of azadirachtin in neem oil cream. Neem oil cream is stable for 4 weeks at 25 oC and for 1 week at 40 oC.
Conclusion: The neem oil cream is physically stable and chemically stable for 4 weeks at a 25°C and 1 week at 40°C.
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