Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF LEVETIRACETAM IN API BY USING RP-HPLC

K. Chandra Mohan*, Dr. Singavruksham Kiran Babu, M. V. K. Satish, Dr. K. S. Natraj, Ganesh, Venkat

ABSTRACT

The goal of the current study was to create and progressively validate a novel, concise, responsive, and stable RP-HPLC method for the evaluation of levetiracetam active pharmaceutical ingredient. Chromatographic conditions were studied under the stationary phase (Phenomenex C8 (150mm x 4.6mm, 5µm), Mobile phase used is Methanol: Water in the ratio of 20:80, flow rate was maintained at 1.0ml/min, detection wave length was 222nm, column temperature was set to 20oC, and diluent was methanol. Conditions were set as the best course of action. The retention time for Levetiracetam was 5.449 min. The standard was injected six times to study system suitability parameters, and the results fell far short of the threshold for acceptance. An analysis of linearity between levels of 25% and 150% revealed an R2 value of 0.999. The results showed that the method precision was 1.1 and the intermediate precision was 0.4. The LOD and LOQ are, respectively, 0.0174 and 0.0529 µg/ml.

Keywords: Levetiracetam, RP-HPLC, Method Development, Validation.