A validated simultaneous estimation of Budesonide and Nifedipine in pharmaceutical formulation by RP-HPLC method

Abstract

A discriminative, easy, quick, precise, economical and isocratic reverse phase high performance liquid chromatographic method was developed and validated for the model drugs chosen in the study viz., Budesonide and Nifedipine in a novel pharmaceutical formulation. The chromatographic elucidation for the method development was carried out with Inspire (250 mm X 4.6 mm and 5 μm i.d using pH 3.0 phosphate buffer solution and acetonitrile in 30:70v/v ratio as mobile phase at a flow rate of 1 ml/min. The isocratic wavelength for both the drugs used in the study was set to 260 nm and detection was carried out using PDA detector at ambient temperature. The developed method was validated for precision, specificity, ruggedness, accuracy, linearity, LOD and LOQ. The calibration curves for Budesonide and Nifedipine were found to be linear in the range of 10 -50 μg/ml and 25 -150 μg/ml con- centration respectively. The retention times for Nifedipine and Budesonide were found to be 2.1 and 3.2 min respectively. Thus, the method developed in the current study can be adopted for quality control analysis of select- ed drug candidates.