Stability indicating RP HPLC method for determination of levitiracetam in pharmaceutical formulation

Abstract

The article reports on a development of RP-HPLC method for the quantitative determination of Levetiracetam in tablet dosage forms. The chromatographic separations were performed using Phenomenex_ C18 (250 mm x 4.6 mm i.d, 5 μm particle size) column at 40 ºC temperatures. The optimum mobile phase consisted of methanol, water and acetonitrile in the ratio of 30:10:60. Auto sampler 20 μl was used and kept at 15 ºC temperature. Analysis was done with flow rate of 1.0 ml/min at 212 nm (_ max of Levetiracetam) wavelength by using photodiode array (PDA) detector. The drug was analyzed for acid, alkaline, oxidative, hydrolytic, photolytic and thermal degradation studies. The standard calibration curve was plotted for the drug and results showed that the drug was linear (r2 = 0.999) in the concentration range between 0.01 – 1.5 μg/ml. The results of stress testing undertaken according to the International Conference on Harmonization (ICH) guidelines reveal that the selected method is selective and stability-indicating for determination of levitiracetam in pharmaceutical formualtion.

Electrochemical Sensor for Levetiracetam Therapeutic Monitoring in Biological Fluid Utilizing Molecular Imprinted Polymer Electrografted onto Pencil Graphite Electrode

“…Statistical analysis.-Statistical analysis on the basis of Student t-test and F value was established For the purpose of comparing the acquired observations with those derived after performing a reported HPLC method 17 in order to ensure the viability of the suggested voltammetric technique for identifying the proposed drug. It was discovered that the computed Student t-test and F value was lower than their respective tabulated ones by setting the p-value at 0.05, indicating that the proposed and the reported methods do not differ significantly from one another and confirming the developed MIP sensor's reliability with regard to LEV quantification as represented in Table V.…”

“…Some of these approaches include spectrophotometric method, 11 gas chromatography mass spectrometry (GC-MS), [12][13][14] HPLC, [15][16][17] HPLC-UV, [18][19][20] ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), 21 capillary electrophoresis, 22 liquid chromatography mass spectrometry (LC-MS), 23,24 and electrochemical method. 25 To the best of our knowledge, only two MIP based technique has been recognized for the investigation of LEV.…”

Stability Indicating RP-HPLC Method for Quantitative Estimation of Levetiracetam and its Impurities in Pharmaceutical Dosage Form

“…The extensive literature survey revealed few methods are developed to estimate the drug Levetiracetam in raw material, tablets and in biological fluids using UV, [4][5][6] RP-HPLC, [7][8][9][10][11][12][13][14][15][16][17] LC-MS, [18][19][20] Capillary electrophoresis, 21 UPLC, 22,23 Gas Chromatography 24,25 and HPTLC. 26 However, there is no stability indicating method developed yet for the estimation of Levetiracetam and its impurities by RP-HPLC in liquid dosage forms.…”