A spectrofluorimetric method has been developed and validated for determination of ivabradine hydrochloride in bulk and marketed formulation, according to ICH guideline. For ivabradine hydrochloride, excitation and emission wavelength was found to be 287 nm and 326 nm. Linear calibration graphs were obtained in the range of 100-700 ng/ml with good correlation coefficient between fluorescence intensity and concentration of the IH in water. Good accuracy and precision were obtained as revealed from % RSD value less than 3. Developed method is simple, reliable and economical that can be useful in routine quality control of bulk drug and pharmaceutical dosage form analysis. Moreover, bioanalytical method with simple protein precipitation as sample preparation was developed for its estimation in plasma and validated according to USFDA guideline for bioanalytical method. Linear calibration graphs were obtained in the range of 10-400 ng/ml with good correlation coefficient between fluorescence intensity and concentration of IH. Extraction recoveries >80% were obtained. Method validation parameters showed % RSD value less than 15. In case of bioanalytical method, high extraction recovery values shows efficiency of sample preparation technique and sensitivity of developed method that can be applied for bioavailability/bioequivalence study.
