Abstract
A selective and new spectrophotometric method is described for determination of three antiepileptic drugs; namely lamotrigine (LAM), gabapentin (GAB), and oxcarbazepine (OXC) in drug substances and in drug products using vanillin reagent as the chromogenic agent. The method is based on a coupling reaction between the cited drugs and vanillin reagent in acidic condition. Under optimized conditions, the yellow colored products were measured at 405, 396, and 400 nm respectively. Beer’s law was obeyed at (0.4 – 10), (0.1-10), and (0.5-11) μg/mL, and the calculated molar absorptivity values are 2.52 x 104, 1.74 x 104, and 2.54 x 104 L/mol/cm for LAM, GAB, and OXC respectively. Sandell sensitivity, the limit of detection (LOD) and limit of quantification (LOQ) were calculated. No interference was observed from common additives found in drug products. The presented method was validated according to ICH guidelines. Statistical comparison of the results was performed using Student's t-test and F-ratio at 95% confidence level, and there was no significant difference between the reference and proposed method with regard to accuracy and precision. The method offers the advantages of rapidity, simplicity and sensitivity and low cost and can be easily applied to resource poor settings without the need for expensive instrumentation and reagents.
Highlights
Lamotrigine (LAM), 3, 5-diamino-6-(2, 3-dichlorophenyl)-1, 2, 4-triazine Figure 1is an anticonvulsant drug
Several analytical methods have been reported for the determination of LAM in pharmaceuticals or in biological fluids including reverse -phase HPLC [4,5,6], GC with nitrogen phosphorous detector[7], capillary electrophoresis[8], adsorptive stripping voltammetry[9,10] and spectrophotometry[1117]
The results revealed that LAM, GAB, and OXA reacted with vanillin in a ratio of 1:1 under the optimum condition attained Figure 6
Summary
Lamotrigine (LAM), 3, 5-diamino-6-(2, 3-dichlorophenyl)-1, 2, 4-triazine Figure 1is an anticonvulsant drug. It has been used successfully to treat epilepsy and bipolar disorder as immunotherapy and as an adjunct with other antiepileptic for treatment of partial and generalized toxic-chronic seizures. It is used to treat neurological lesions and as a tranquilizer [1, 2]. LAM is the subject of monographs in the United States Pharmacopeia[3] where by potentiometric method is recommended for its determination. The objective of the present work is to develop simple, rapid and precise UV spectroscopic method for the determination of lamotrigine in drug substance and in drug products
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