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 x 4.6mm] 5 column and U.V. detector at  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 (r2
) ≥ 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.