A validated stability-indicating HPLC related substances method for salicylic acid in bulk drug and dosage form

Abstract

A Reverse Phase High Performance Liquid Chromatography (RP-HPLC) was developed for quantitative determination of salicylic acid in bulk drugs and in pharmaceutical dosage form. The developed method is stability indicating which separates the drugs from its degradation products and is also applicable for related substances determination of salicylic acid in bulk drugs. The chromatographic method separation was achieved   on a Kromasil 60-5CN (250 X 4.6) mm, 5 µ column and the mobile phase containing the mixture of mobile phase-A is the mixture of 1.0 mL of trifluoro acetic acid in 1000 mL purified water and mobile phase-B is acetonitrile (70:30, v/v). The detection was carried out at wave length 230 nm and column oven temperature at 30°C. Forced degradation studies were performed for Salicylic acid using acid (0.1 N HCl), base (0.1 N NaOH), Oxidation (2% H₂O₂) and thermal (80 ^oC) degradation. The degradation was observed for Salicylic acid in Acidic, Basic and Oxidative degraded   products   were well   resolved from main peak. The developed method was validated with respective linearity, accuracy, precision, robustness, and forced degradation studies prove stability indicating power of the method.