Abstract

REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF ATENOLOL AND NIFEDIPINE IN A CAPSULE FORMULATION

*Sahaya Asirvatham, Neelam Sachin Kamble

Abstract

A simple, rapid, precise and accurate reversed phase high performance liquid chromatographic method has been developed for simultaneous determination of Atenolol in combination with Nifedipine. This method uses a mobile phase of 0.01M phosphate buffer solution: methanol (50:50 v/v, pH 4.0). The retention times for Atenolol and Nifedipine are 1.8 min and 7.7 min, respectively. The method is validated and shown to be linear. The linearity range for both Atenolol and Nifedipine was found to be 10-100 μg/ml. The Percentage recovery for Atenolol and Nifedipine are ranged between 99.32– 100.02 and 99.10–100.4 respectively. The correlation coefficients of Atenolol and Nifedipine are 0.999 and 0.999 respectively. The relative standard deviation for six replicates is always less than 2%. The Statistical analysis proves that the method is suitable for analysis of Atenolol and Nifedipine as a bulk drug and in pharmaceutical formulation without any interference from the excipients. The propose method was validated as per the ICH guidelines parameters like Linearity, precision, accuracy, robustness limit of detection and limit of quantitation. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.

Keywords: Atenolol, Nifedipine, validation, ICH guidelines.