Quantitative Determination and Validation of Ivabradine HCL by Stability Indicating RP-HPLC Method and Spectrophotometric Method in Solid Dosage Form

Abstract

A highly sensitive, selective, reproducible, rapid and stability indicating RP-HPLC and spectrophotometric method has been developed and validated successfully for analysis of a new anti angina agent Ivabradine HCL in solid dosage form. Separation and detection of Ivabradine HCL by HPLC was achieved by Inertsil ODS-3V [250 mm * 4.6mm] 5 m column and U.V. detector at l 286 nm respectively. In HPLC method the retention time was about 7 minutes. Complete validation study for both the methods was carried out according to ICH guideline. Linearity of both the methods was achieved in the range 4.2 to 31.6 µg mL -1 with a correlation coefficient (r 2 ) ≥ 0.999. The limit of detection and the limit of quantification were 0.06 µg mL -1 and 0.2 µg mL -1 respectively. The intra-day and inter-day precision and accuracy values for both methods were within the assay variables as per the ICH guideline. The HPLC method can be used for the routine quantitative determination and stability study of Ivabradine HCL in Pharmaceutical dosage forms, since it proved to be stability indicating also.