Determination of manidipine hydrochloride in bulk drug and tablets by high-performance liquid chromatography

Abstract

A validated stability-indicating HPLC method was developed for determination of Manidipine hydrochloride in bulk drug and tablets. The system comprised of a Symmetry C-18 (4.6 x 150 mm, 3.5 μm) as stationary phase, a 45 : 55 mixture of ammonium formate buffer (25 mM, pH 3.1) as mobile phase, flow rate of 0.7 ml/min, column temperature at 30oC and detection wavelength at 230 nm. The stress-testing was carried out under the conditions of hydrolysis, oxidation, photolysis and thermal degradation The developed method was validated for specificity, linearity and range, precision, accuracy, limit of detection, limit of quantification, stability of solutions, and system suitability. The linearity of the proposed method was in the range of 50 - 150 μg/ml. The system precision and method precision expressed as the relative standard deviation were less than 2%. The accuracy expressed as the percentage recovery was 99.4. The limit of detection and quantification were 0.141 and 0.427 μg/ml, respectively. The purposed method was successfully applied to the direct determination of Manidipine hydrochloride in tablet formulations