Development and validation of stability-indicating assay method for lacosamide by RP- HPLC

Shah, Sachin and Vasantharaju, SG and Karthik, Arumugam and Muddukrishna, BS (2011) Development and validation of stability-indicating assay method for lacosamide by RP- HPLC. Elixir Pharmacy, 38. pp. 4174-4177.

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Abstract

The present study describes degradation of Lacosamide under various conditions like, oxidation, hydrolysis, and thermal stress conditions. The drug was found to hydrolyse in acidic and alkaline conditions and no degradation was found in thermal stress condition and oxidation. The separation of the drug and degradation product was successfully achieved on a C18 column utilizing water (0.1 % triethylamine and pH 3.0±0.05 was adjusted using Orthophosphoric acid 85%v/v) and methanol in the ratio of 70:30 v/v. The detection wavelength was 215 nm. The method was validated with respect to linearity, precision, accuracy, and specificity. The response was linear in concentration range of 1 - 20 μg/mL. The value of slope and correlation coefficient found to be 42506 and 0.9996 respectively. The R.S.D value for intra- and inter- day precision studies were <1.169 and <1.263, respectively. The recovery of the drug ranged between 98.81 and 101.76% from a mixture of degradation sample.

Item Type: Article
Uncontrolled Keywords: HPLC, ICH, Lacosamide, Stability-indicating method, Stress testing
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC EPrints Administrator
Date Deposited: 21 Dec 2011 06:36
Last Modified: 21 Dec 2011 06:36
URI: http://eprints.manipal.edu/id/eprint/1893

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