Development and Validation of Simultaneous Estimation Method for Amoxycillin Trihydrate and Tinidazole in Tablet Dosage Form by RP-HPLC

A reversed phase high performance liquid chromatography method was developed and validated to measure Amoxycillin Trihydrate and Tinidazole at single wavelength (240 nm) in order to perform assay of drug from tablet formulation. The isocratic method was developed on Hiq Sil, C-18, V size (250mm ∗4.6mm, 5μ) column with disodium hydrogen phosphate buffer (pH 3.6): acetonitrile mobile phase in ratio of 30:70 delivered at 1.0 ml/min. The selected chromatographic conditions were found to separate amoxycillin trihydrate (Rt=1.903 min) and tinidazole (Rt=4.410 min) having a resolution of 7. Results of the analysis were validated statistically as per ICH guidelines. The percentage recoveries for amoxycillin trihydrate and tinidazole ranged from 99.85% and 99.75% respectively. The limit of detection was found to be 1.063μg/ml and 0.5535μg/ml for amoxicillin trihydrate and tinidazole respectively. Limit of quantification was found to be 3.189μg/ml and 1.660μg/ml for amoxycillin trihydrate and tinidazole respectively. All results were acceptable and confirmed suitability of the method for its intended use in routine quality control and assay of drugs.