Stability Indicating RP-HPLC method Development and Validation for the Estimation of Enoxaparin sodium in marketed formulation

Abstract

A novel rapid, sensitive and reproducible stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of Enoxaparin sodium (ENXP) in the bulk drug and in a pharmaceutical dosage form. Use of Thermo C₁₈ analytical column (250mm.6 mm i.d., 5.0?m) with 10mM KH₂PO₄: Methanol in the ratio of 20:80% v/v as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 234nm. The method was validated for linearity, accuracy (recovery), precision, specificity and robustness. The linearity of the method was satisfactory over the range 5-25?g/ml (correlation coefficient 0.999). The limits of detection and quantification of Enoxaparin sodium were 0.075 and 0.225 respectively. Recovery of Enoxaparin sodium from the pharmaceutical dosage form ranged from99.193-98.593% respectively. Enoxaparin sodium was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the samples were analyzed by developed method. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of Enoxaparin sodium as bulk drug, in respective dosage forms for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.