Lawsonia inermis L. (Lawsone) is an analgesic, hypoglycemic, hepatoprotective, immunostimulant, anti-inflammatory, antibacterial plant drug which have a unique pharmacological action. A stability-indicating RP-HPLC method was developed and validated for the determination of lawsone by using enable C18 column (150 × 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of acetonitrile: methanol: water (34:66, v/v) with a flow rate of 1.0 ml/min (UV detection- 269 nm). The retention time was found to be 7.4 min. Linearity was observed between the concentration range of 40 μg/ml to 90 μg/ml and the correlation coefficient R2 value was found to be 0.999±00.13. The method is accurate and recovery was found to be in the range of 100-101.9%. The limit of detection of lawsone was found to be 6.28 μg/ml and limit of quantitation was found to be 19.05 μg/ml. Lawsone was subjected to stress conditions including acidic, alkaline, neutral, oxidation and dry heat degradation. Lawsone is more sensitive to acidic and oxidative degradation. The method was validated according to ICH guidelines.
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