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A validated stability indicating LC assay method for pregabalin in bulk drugs and pharmaceutical dosage forms

Ravi Kiran Kaja, K.V.Surendranath, P.V.V Satyanarayana, K.Suresh Kumar

A novel, sensitive gradient RP-LC assay method has been developed for the quantitative determination of Pregabalin in bulk drugs and Pharmaceutical dosage forms. Pregabalin is an anti-epileptic drug. Efficient chromatographic separation was achieved using C18 stationary phase with simple mobile phase combination delivered in a gradient mode and quantitation was carried out using ultraviolet detection at 210 nm. The mobile phase consists of buffer and methanol delivered at a flow rate of 1.0 mL min-1. Buffer consists of 5 mM di-potassium hydrogen phosphate anhydrous, pH adjusted to 7.0 by using ortho phosphoric acid. In the developed HPLC method the resolution (Rs) between Pregabalin and its all degradation products was found to be greater than 2.0. Regression analysis shows an rvalue (correlation coefficient) of greater than 0.99 for Pregabalin. The inter and intraday precision values for Pregabalin was found to be within 2.0% RSD at its specification level. The method has shown good and consistent recoveries for Pregabalin (99.2-101.2%) in bulk drugs and (98.0-100.2%) in dosage forms. The test solution was found to be stable in diluent for 48 h. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Considerable degradation was found to occur in acid hydrolysis, base hydrolysis and oxidative stress conditions. The stress samples were assayed against a qualified reference standard and the mass balance was found close to 99.5%. The developed RP-LC method was validated with respect to linearity, accuracy, precision and robustness.