Optimization and Establishment of Validated stability indicating RP-HPLC Method for Simultaneous Estimation of Mefenamic acid and Paracetamol from Tablet Dosage Form

摘要

A simple, selective and precise gradient HPLC method has been developed for simultaneous estimation of Mefenamic acid and Paracetamol combination from pharmaceutical dosage form. The separation was accomplished on an HiQSil reversed phase C18 column, 250 mm x4.6mm I.D., 5um column using two mobile phases i.e. A as methanol: 50mM potassium dihydrogen orthophosphate (pH = 7.5)(20:80 v/v) and B as methanol in a gradient elution mode. The flow rate was lmL/min. The eluents were monitored with a UV detector set at 245 nm as detection wavelength. The investigated validation elements showed the method has acceptable specificity, accuracy, linearity, precision, robustness and high sensitivity. Detection and quantification limits were established at 0.02 μg/ml and 0.05 μg/ml respectively. A stability indicating HPLC method has been established for analysis of Mefenamic acid and Paracetamol combination. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal decomposition.