Development and Validation of HPLC Method for Simultaneous Estimation of Amoxycillin Trihydrate and Potassium Clavulanate in Pure and Marketed Tablet Dosage Form

Abstract

A rapid, sensitive and specific RP-HPLC method involving UV detection was developed and validated for determination and quantification of Amoxycillin Trihydrate and Potassium Clavulanate. Chromatography was carried out on pre-packed Inertsil C18 (5µm, 250×4.6mm) column using filtered and degassed mixture of Methanol: Aqueous disodium hydrogen phosphate pH 5 as mobile phase at flow rate of 1.0 ml/min and effluent was monitored at 249 nm. The method was validated in terms of Linearity, precision, accuracy, specificity, limit of detection, limit of quantification as per the ICH guidelines.The assay was linear over the concentration range of amoxycillin trihydrate and potassium clavulanaterespectively.The accuracy and precision were found to be within the specified limits. The method does require only nine minutes as run time for analysis which proves its adoptability.