Quantitative Determination and Validation of Ivabradine HCL by Stability Indicating RP-HPLC Method and Spectrophotometric Method in Solid Dosage Form
Year: 2010
Type: article
Abstract: A highly sensitive, selective, reproducible, rapid and stability indicating RP-HPLC andspectrophotometric method has been developed and validated successfully for analysis of a new antiangina agent Ivabradine HCL in solid dosage form. Separation and detection of Ivabradine HCL byHPLC was achieved by Inertsil ODS-3V [250 mm x 4.6mm] 5 column and U.V. detector at 286 nmrespectively. In HPLC method the retention time was about 7 minutes. Complete validation study forboth the methods was carried out according to ICH guideline. Linearity of both the methods wasachieved in the range 4.2 to 31.6 µg mL-1 with a correlation coefficient (r2) ≥ 0.999. The limit ofdetection and the limit of quantification were 0.06 µg mL-1 and 0.2 µg mL-1 respectively. The intra-dayand inter-day precision and accuracy values for both methods were within the assay variables as perthe ICH guideline. The HPLC method can be used for the routine quantitative determination andstability study of Ivabradine HCL in Pharmaceutical dosage forms, since it proved to be stabilityindicating also.
Authors: Shweta Maheshwari, Amit P. Khandhar, Anurekha Jain
Institution: Zydus Lifesciences Limited (India)
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W1481900148