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Stability Indicating RP-HPLC method Development and Validation of Salicylic Acid in Choline Magnesium Trisalicilate (Trilisate) Tablets

Pushpa Kumari K, Gowri Sankar, P. Sowjanya and S. Madhubabu

A stability indicating RP-HPLC method was developed and validated for the determination of Salicylic acid in Trilisate tablets using Xorabax XBD C18 column (150 × 4.6 mm, 5 μm) with mobile phase consisting of Phosphate buffer (pH 3.0), methanol (80:20 v/v) with a flow rate of 1ml/min. Detection was carried out at 230 nm. Retention time was found to be 4.6 min. Linearity was observed over the concentration range of 5-30 μg/ml (R2=0.999) with regression equation y=30.55x+5.302. Salicylic acid was subjected to stress conditions including acidic, alkaline, photolysis and thermal degradation. The drug is more sensitive towards alkaline degradation. The method was validated as per ICH guidelines.