Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

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Stability Indicating HPLC Method Development and Validation of Lamotrigine in Bulk and Tablet Dosage Form

Author(s): Firke Sandip D, Narkhede Mahesh S, Patil Ravindra R, Surana Sanjay J

A simple, precise, linear stability indicating RP-HPLC method was developed and validated as per ICH guidelines for the determination of lamotrigine in the bulk drug and tablet dosage form. Chromatographic separation was performed by using agilant HPLC 1200 series include isocratic mode on a C18 Qualisil BDS (250 mm × 4.5 mm × 5 mm) column using mobile phase containing potassium dihydrogen ortho phosphate buffer (pH 7.4) and methanol in the ratio 60: 40 at flow rate 1.3 ml/min. The wavelength for detection was 305 nm at room temperature. The retention time for separation was 5.3 min and linearity of lamotrigine was perceived in the concentration range of 5-30 μg/ml with correlation coefficient of 0.999. Force degradation of lamotrigine was completed under acidic, basic, oxidation, dry heat and photolytic conditions. The method was found precise, linear, and accurate as per ICH guidelines and may be used as an alternative method in industry.

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