Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ENALAPRIL MALEATE AND FELODIPINE IN BULK AND TABLET DOSAGE FORM

Gandla. Kumara Swamy*, JM Rajendra Kumar , J.V.L.N.Seshagiri Rao

Abstract

The Proposed work was to develop and validate a simple, Accurate and precise, linear and stability indicating RP‐HPLC method for simultaneous determination of Enalapril Maleate and Felodipine in bulk and tablet formulation. This method is simple and Robust as both peaks are well separated from its excipient peaks and with total runtime of 12 min. Moreover proposed method is more accurate, more precise, more stable and robust developed method. In RP-HPLC, analysis is carried out using Potasium di hydrogen phosphate (KH2po4 )Buffer-Acetonitrile(75:25v/v) pH 3.0 adjusted With Ortho-Phosphoric Acid and added Tri ethyl amine as a mobile phase and Phenomenex LUNA C18, column (150mm × 4.6 mm id 5μm) as stationary phase at 237nm and 1 ml/min flow rate. The retention times were found to be 1.96 and 8.25minutes for Enalapril Maleate and Felodipine respectively. Linearity was obtained in the concentration range of 25-150 μg/ml for both ENM and FDN respectively. The % recoveries studies were found to be 98.57% – 100.17% and 98.85% –99.78% for Enalapril Maleate and Felodipine respectively. Limit of Detection and Limit of Quantification for Enalapril Maleate was found to be 3.2μg/ml and 9.5 and for Felodipine 3.0μg/ml and 10.0 respectively. Stability method shows that in stress conditions i.e. acidic, basic, oxidation, thermal and photolytic, comparison of % degradation of tablet dosage form of drug and its Active Pharmaceutical Ingredient( API) is satisfactory and less. As per ICH guidelines HPLC method for Enalapril Maleate and Felodipine was developed and validated.

Keywords: Enalapril Maleate, Felodipine, Reverse Phase HPLC forced Degradation studies, Pharmaceutical dosage form