Rapid Stability-indicating RRLC Method for Simultaneous Estimation of Irbesartan and its Related Impurities
Analytical Research, Product and Technology Development, ecoLogic Technologies Limited, Hyderabad-500 072, 1Department of Chemistry, Gitam Institute of Science, GITAM University, Visakhapatnam-530 004, India
K. Tirumala Rao Analytical Research, Product and Technology Development, ecoLogic Technologies Limited, Hyderabad-500 072 E-mail: [email protected]
A green, novel gradient stability-indicating reverse phase rapid resolution liquid chromatographic method was developed and validated for simultaneous estimation of irbesartan and along with six related impurities in active pharmaceutical ingredient samples. The chromatographic separation was achieved on Kromasil C8 (3.5 µm, 150×4.6 mm) short column with 0.1% v/v ortho-phosphoric acid and acetonitrile as mobile phase using gradient elution. The developed method showed good resolution between irbesartan and its six related impurities and were eluted within 15 min. run time of LC chromatogram. Regression analyses indicate correlation coefficient value greater than 0.999 for irbesartan and its six related impurities. The limit of detection for irbesartan and the known related impurities were observed at a level below 0.004% (0.019 µg/ml and the method is showing better recoveries for irbesartan (99.6–100.7%) and also for its six known impurities (88.5–98.9%). The test solution and related substances were found to be stable in the diluents for 24 h. The developed stability-indicating method is found to be rapid, accurate, precise, linear, specific, sensitive, rugged, robust, and stability-indicating. The application of developed method was also verified by an assay of irbesartan and related substances in commercial API bulk drug samples and more essentially, the method is economic and environment friendly than the other published methods.