HYDROPHILIC INTERACTION LIQUID CHROMATOGRAPHY: A WORTHY TECHNIQUE FOR THE DETERMINATION OF LAMOTRIGINE IN TABLETS AND HUMAN PLASMA

Abstract

A rapid, stability indicating hydrophilic interaction liquid chromatography (HILIC) method was developed for the determination of lamotrigine and its induced alkaline degradation product. The separation was performed on an unmodified silica column adopting UV detection at 290 nm with flow rate of 1.5 mL min⁻¹. The mobile phase consisted of a mixture of acetonitrile:ammonium formate 0.01 M (85: 15, v/v) and the pH was adjusted at 5.0. The method showed good linearity in the range of 0.5-10 µg mL⁻¹ with lower limit of detection (LOD) 0.1 µg mL⁻¹ and limit of quantification (LOQ) 0.5 µg mL⁻¹, respectively. The proposed method was applied to tablets assay and was further extended to the in vitro and in vivo determination of the drug in spiked and real human plasma. The mean percentage recoveries were 100.32 ± 2.59 (n = 3) and 95.63 ± 4.42 (n = 3), respectively. Kinetics for the stability study was performed.

Keywords:

• forced degradation
• HILIC
• kinetics
• lamotrigine
• spiked and real human plasma
• tablets

Notes

^a Degradation rate constant.

^b Half life time.

^c The activation energy.

^a Standard deviation of the residuals.

^b Standard deviation of the intercept of regression line.

^c Standard deviation of the slpoe of regression line.

^d Percentage relative standard deviation.

^a The values of tabulated t and F are 2.776 and 19.00, respectively at P = 0.05^[31].