Stability indicating HPLC method development and validation for quantification of salicylic acid impurity in acetaminophen aspirin caffeine oral solid dosage forms

The present study discusses the development of simple isocratic reversed-phase HPLC method was developed and validated for the quantification of Salicylic acid, itwas amajor degradant impurity of Aspirin, in the Acetaminophen Aspirin Caffeine Tablet dosage formulations. The analytes were separated on a C18 Zodiac column (100mm x 4.60 mm i.d., 5 μm particle size). A mobile phase, water, MeOH, Glacial acetic acid in the ratio of (690:280:30) (v/v/v) were used. The column temperature 45℃ and flow rate 2.0ml/mint.The UV detection was made at 302 nm for Salicylic Acid. The HPLC method was obtained highly specific with linearity concentration ranging between 0.373- 112.079μg/mL of salicylic Acid, and the correlation coefficient was found to be >0.999 The method showed high accuracy more than 97%. The limit of detection(LOD) for Salicylic acid was0.41μg/ml, respectively. The limit of quantification (LOQ) for salicylic acid was 1.25μg/ml,respectively. Validation acceptance criteria were met in all cases. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, precision, accuracy and robustness. In stress studies the Acetaminophen Aspirin and caffeine tablets were found to be sensitive inAcid, Base stress conditions and Oxidation stress condition. Theproposed method was established to be precise and stability indicating as no interfering peaks of degrades and excipients were observed. The proposed method is suitable for purpose in quality control laboratories forquantitative analysis of salicylic acid in Acetaminophen Aspirin and caffeine tablet, as it is simple and rapid with tremendous precision and accuracy.