Development and validation of stability indicating RP-HPLC method for simultaneous estimation of Atenolol and Nifedipine in bulk and pharmaceutical dosage form

Abstract

A simple, rapid, selective, sensitive, linear, precise and accurate stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Atenolol and Nifedipine in pharmaceutical dosage form. Separation was attained on a STD Kromasil C18 (150 x 4.6 mm, 5 μ particle size) column at 30°C using a mobile phase consisting of phosphate buffer (pH 5.0) and acetonitrile in the ratio of 45: 55% v/v, at a flow rate of 1.0 ml/min. The UV detection wavelength was 232 nm and 10 μl of sample was injected. The linearity was found to be 15–90 μg/ml for Atenolol and 6–36 μg/ml for Nifedipine with a correlation coefficient of 0.9993 and 0.9994, respectively. Retention times were found to be 2.474 min and 4.553 min for Atenolol and Nifedipine, respectively. The overall mean % recoveries were found to be 99.69% for Atenolol and 99.68% for Nifedipine. The method was validated as per the ICH guidelines for sensitivity, linearity, accuracy and precision. The % RSD for precision, robustness and ruggedness of the proposed method was found to be less than 2%. Further forced degradation studies were conducted for indicating the stability of the method developed. Hence the developed method can be successfully employed for routine quality control analysis of Atenolol and Nifedipine in pharmaceutical dosage forms.