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Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF LACOSAMIDE AND ITS RELATED SUBSTANCE IN PARENTERAL DOSAGE FORM

Ankita Y. Chauhan*, Dr. C. J. Patel and Dr. M. M. Patel

ABSTRACT

A reverse phase high performance liquid chromatography method has been developed and subsequently validated for determination of lacosamide and its related substance in parenteral dosage form. Chromatographic separation was achieved in gradient mode with Ascentis express C18 (50 mm x 4.6mm I.D, particle size 2.7μm) column with mobile phase A containing buffer and methanol in the ratio 92:8 v/v. The buffer was prepared by diluting 1 ml of orthophosphoric acid in 1000 ml of purified water. Mobile phase B containing Acetronitrile as eluent at a flow rate of 1.0 ml/min and total elution time was 50 minutes. The UV detection was performed at 215 nm and column temperature was 30ºC. The injection volume is 10μl. Lacosamide was subjected to acid and alkali hydrolysis, and peroxide degradation. Also the degraded products were well separated from the pure drug. The linearity observed for amino impurity is in the range of 0.20-15.17 μg/ml and for desmethoxy impurity is 0.20-3.11 μg/ml. The recovery was found to be in the range of 100.6-101.3 % for amino impurity and 90.2-93.96 % for desmethoxy impurity. RSD % Recovery should not be more than 5. The proposed method was successfully applied for the determination of lacosamide and its related substance in routine quality control analysis in parenteral dosage form.

Keywords: Lacosamide, method development, RP-HPLC, Validation.


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