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Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC ASSAY METHOD FOR DETERMINATION OF LAMOTRIGINE IN TABLET FORMULATION

Rashid Ahmad *, Pushpendra Soni, Lavakesh Kumar Omray

Radharaman Institute of Pharmaceutical Sciences, Bhopal

ABSTRACT

The objective of the current study was to developed simple, precise and accurate isocratic reversed-phase stability indicating high performance liquid chromatography (HPLC) assay method and validated for determination of lamotrigine in solid pharmaceutical dosage forms. Isocratic RP-HPLC separation was achieved on a Thermo C18 column (250 mm x 4.6 mm i.d., 5 μm particle size) using mobile phase of Acetonitrile: Buffer (1.75 gm KH2PO4 in 1000 ml of water add 1 ml of TEA and adjust the pH 6 with OPA, 40:60, v/v) at a flow rate of 1.0 ml/min and the detection was carried out at 225 nm by using photo-diode array detector. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The retention time was 5.013 + 0.3 min and the method was linear in the drug concentration range of 5-25 μg/ml with a correlation coefficient 0.999. The percentage relative standard deviation in accuracy and precision studies was found to be less than 2%. The accuracy (recovery) was between 99.830and 100.208 %. Degradation products produced as a result of stress studies did not interfere with detection of lamotrigine and the assay can thus be considered stability indicating.

Keywords: Lamotrigine, Method Development, Validation, RP-HPLC, Stability indicating


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