Analytical method validation for the determination of assay of levetiracetam in levetiracetam injection formulation by HPLC

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Aakisetti Siva Sankar , SrinivasaRao


  • To develop and validate a effective stability indicating HPLC procedure to assay levetiracetam in pure and applied on injection formulations containing levetiracetam.For chromatographic separation and analysis, the mobile phase consisted of potassium phosphate buffer (pH 5.5) and acetonitrile (45:55, v/v). The separation was achieved on an YMC-pack AQ (3µm, 150 × 4.6 mm) column in isocratic mode. The method was validated following the recommendations of ICH. The method for levetiracetam assay has been shown to be precise, accurate, specific, rugged and robust. The procedure was also proved as stability indicating, as the major degradation products and excipients were not interfering with levetiracetam assay. An effective stability indicating HPLC method has been developed and validated for the determination of levetiracetam in pure and applied successfully on injection formulations containing levetiracetam

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