DEVELOPMENT OF THE METHODOLOGY OF THE CHROMATOGRAPHIC DETERMINATION OF NIFEDIPINE IN MEDICINES

ABSTRACT Objective: The aim was to develop a simple, rapid, less expensive, linear, precise, and accurate reverse phase high performance liquid chromatography method for determination of nifedipine in tablets. Methods: The chromatographic analysis of nifedipine was performed using liquid chromatograph Agilent 1290 Infinity II LC System. Selected conditions were isocratic elution with binary mobile phase consisting of solution methanol and 0.1% trifluoroacetic acid (55:45). Detection was carried out using spectrophotometric detector at 265 nm. The method was validated as per ICH guidelines. Results: The retention time for nifedipine by proposed high performance liquid chromatography (HPLC) method is observed as 3.5 minutes. The correlation coefficients are 1.0000. The developed chromatographic method was found to be accurate with recovery 99.2-99.8% and was found within the acceptance criteria (i.e. 98.0-102.0%) with acceptable % relative standard deviation of not more than 2% at each level. The assay results of nifedipine in tablets by developed method are highly reproducible, reliable and are in good agreement with the label claim of the medicines (average 99.62 %). Conclusion: Finally, it should be noted that a new simple, rapid, linear, precise, accurate HPLC method was developed and validated for the determination of nifedipine in medicines in accordance with the ICH guidelines. These results show the method are accurate, precise, sensitive, economic, and rugged. The proposed HPLC method is rapider (retention time is 3.5 minutes). This method can be useful for the routine analysis of nifedipine in pharmaceutical dosage form. Keywords: Nifedipine, High-performance liquid chromatography, Validation, Linearity, Accuracy, Range of application.