Abstract
This paper describes a validated method for the quantification of amino guanidine in Lamotrigine drug substances and their intermediates using Ion Chromatography (IC), with out any dervitization process. It was analysed using a Ion pac CS17 250 x 4.0 mm column with guard column CG17 50 x 4.0 mm, with a flow rate of 1.5 mL/min with injection volume of 20µL with conductivity detection with CSRS 300 x4.0mm suppressor with suppressor current 40 mA and having only 10 minutes runtime with methanol as diluent. It has the mobile phase of 20% v/v Milli-Q-Water and 80% v/v of 10 mM methane sulphonic acid solution. The method is validated for its Specificity, Precision, Accuracy, Linearity, Ruggedness and solution stability. Aminoguanidine is linear from 1 μg/ml to 25 μg/ml with correlation coefficient 0.9999. Limit of Quantitation of the method is 1 μg/ml and Limit of Detection is 0.3 μg/ml.
Highlights
RESULTS AND DISCUSSIONFull method validation of the procedure was performed as per ICH guidelines which includeprecision, linearity, specificity, ruggedness, accuracy, ruggedness and solution stability
6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine, sold as Lamotrigine (Fig 1), is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder
Ion chromatography is a process that allows the separation of ions and polar molecules based on their charge
Summary
Full method validation of the procedure was performed as per ICH guidelines which includeprecision, linearity, specificity, ruggedness, accuracy, ruggedness and solution stability. Precision: The system precision of the procedure was determined by performing six replicate injections of Standard amino guanidine with 10 ppm of concentration and determining the relativestandard deviation (R.S.D ) of the areas of amino guanidine peaks. The Method precision was determined by injecting six independent preparations of sample. The precisionof the replicate injections of the samples was
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
