M. Lohita*, S. Shakirbasha, T. Edukondalu, S. Vijayaraj, P. Jayapreethi, K. Swetha Department of Pharmacy, Sree Vidyanikethan College of Pharmacy, Sree sainath Nagar, A. Rangampet, Tirupathi–517102, Chitoor (Dt), Andhra Pradesh, India. Received: 15 May 2014, Accepted: 21 June 2014, Published Online: 18 July 2014
A simple, selective, precise and accurate ”AUC” and ”FIRST DERIVATIVE” methods for estimation of Levetiracetam drug in bulk and formulation by using UV spectrophotometric method was developed and validated. The solvent used was 0.1N sodium hydroxide and water. Levetiracetam was detected at 282 nm at room temperature. The linear regression analysis data for the linearity plot showed good linear relationship with correlation coefficient value, R2 = 0.998 in the concentration range 10 – 60 µg/ml with slope 0.008, intercept -0.021. The method was validated according to the International Conference on Harmonization (ICH) guidelines for linearity, range, accuracy, precision and specificity and applied on bulk powder and pharmaceutical formulations. Levetiracetam was determined in sterile dosage form in range of 99.42% with 0.131 standard deviation. The accuracy of the method was validated by recovery studies and was found to be significant and under specification limits, with % Recovery 85 – 103.8 (within acceptable range (85 -103%).
Keywords: UV spectrophotometer, Levetiracetam, sodium hydroxide, validation