%0 Journal Article
%T A Stability-Indicating Liquid Chromatographic Method for the Quantification of New Anti-Epileptic Drug Lacosamide and its Intermediates
%A Parmar Manoj D
%A Kiran Nimavat
%A Kartik Vyas
%A Rao DVNS
%J International Journal For Pharmaceutical Research Scholars
%D 2012
%I International Journals for Pharmaceutical Research Scholars
%X A simple, selective, precise, and stability-indicating high performance liquid chromatography (HPLC) method has been established and validated for the determination of S (每) Enantiomer in Lacosamide drug substance. The chromatographic system used normal phase DAICEL Chiralcel OD-H column with UV-Vis detection at 210 nm. The mobile phase was a mixture of n每hexane每ethanol, 74:6 (%, v/v) and this mixture was transferred to isopropyl alcohol每trifluoroacetic acid in the ratio of 72:6:0.08 (%, v/v). The method is validated for its specificity, precision, accuracy, linearity and ruggedness. Regression analysis data for the calibration plots were indicative of good linear relationships between response and concentration over the range 0.0174米g mL每1 每 5.398 米g mL每1. The correlation coefficient, r2, was 0.9994 and 0.9988. The value of slop and intercept of the calibration plot was 79403 and -16673. The limit of detection and quantitation were 0.087 ㊣ 7.18 米g mL每1 and 0.263 ㊣ 3.68 米g mL每1. Statistical analysis proved the method is repeatable, selective, and accurate for estimation of S (每) Enantiomer in Lacosamide drug substance and its intermediates. Because the method could effectively separate the drug from their possible impurities like dibenzyl urea, benzyl acetamide, desmethyl, diacetyl and methylbenzyl serine, it can be used as a stability indicating method.
%K Normal phase
%K HPLC
%K UV-Vis detection
%K Chiralcel OD-H column
%K Limit of Quantitation
%K and Limit of Detection
%U http://www.ijprs.com/download.php?file=1343828924.pdf