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Lamotrigine, A Very Polar Compound
      USP Assay Method

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Note: Lamotrigine is a phenyltriazine anticonvulsant used to treat epilepsy and type I bipolar disorder. It is believed to act as a sodium channel blocker.
Method Conditions



Column Cogent Bidentate C18™, 4µm, 100A
Catalog No. 40018-15P
Dimensions 4.6 x 150 mm
Solvents A: 2.7 g/L KH2PO4: triethylamine 150:1, adjusted to
    pH 2.0 with H3PO4
B: acetonitrile
Gradient
time (min.) %B
0 23.5
4 23.5
14 80
15 23.5
19 23.5
Injection Volume 10 microL
Detection UV 270 nm
Sample 25 mg strength tablet was ground and dissolved in 5
mL MeOH in a 100 mL volumetric flask. The flask
was diluted to mark with 0.10 M HCl. It was
sonicated and filtered with a 0.45 µm nylon filter
(MicroSolv Tech Corp).
Peak Lamotrigine
t0 1.9 min

Discussion

The USP assay method for lamotrigine uses a relatively low pH of 2.0. These conditions may promote hydrolysis of the bonded phase in conventional L1 columns, but the unique chemistry of the Cogent Bidentate C18™ column is very rugged and shows no loss of retention for the API, as the five run overlay in the figure shows. The retention time %RSD for the five runs was 0.15%. In addition the peak shape was highly symmetrical.




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